Regulations Of The Food And Drug Supervisory Agency Number Hk. 03.42.06.10.4556 In 2010

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor HK.03.42.06.10.4556 Tahun 2010

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BN 361-2010 _ BPOM. doc _ REPUBLIC of INDONESIA No. 361,2010 food and drug Supervisory Agency. Operational Instructions. The Manufacture Of Cosmetics. REGULATION OF THE HEAD OF THE FOOD AND DRUG SUPERVISORY AGENCY OF THE REPUBLIC OF INDONESIA NUMBER HK. 03.42.06.10.4556 of the OPERATIONAL GUIDELINES for INSTRUCTIONS HOW to MANUFACTURE COSMETICS with the GRACE of GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: that in order to implement the decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.3870 in 2003 on guidelines for Making cosmetics Either, it needs to set the rules of the Chief food and drug Watchdog Agency about the operational Instructions Manual how to manufacture of Cosmetics; Remember: 1. Act No. 8 of 1999 on the protection of the consumer (State Gazette of the Republic of Indonesia Number 42 in 1999, an additional Sheet of the Republic of Indonesia Number 3821); 2. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia www.djpp.depkumham.go.id 2010, no. 361 2 144 Number in 2009, an additional Sheet of the Republic of Indonesia Number 5063); 3. Government Regulation Number 72 in 1998 about Security Preparations pharmaceutical and health equipment (State Gazette of the Republic of Indonesia Number 138 in 1998, an additional Sheet of the Republic of Indonesia Number 3781); 4. Government Regulation Number 51 of 2009 about Kefarmasian Jobs (Gazette of the Republic of Indonesia Number 124 in 2009, an additional Sheet of the Republic of Indonesia Number 5023); 5. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities and the Organization of work of the Department of Non Government agencies as it has several times changed the last presidential regulation Number 64 in 2005; 6. Presidential Decree Number 110 in 2001 about the Task and Organizational Unit Echelons of Non Government agencies I Department as it has several times changed the last presidential regulation Number 52 in 2005; 7. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM 2001 about the Organization and the Work of drug and food Supervisory Agency as amended by decision of the head of the food and drug Supervisory Agency Number HK. 00.05.21.4231 2004; 8. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.1745 in 2003 about Cosmetics; 9. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.3870 in 2003 about the guidelines of how to Manufacture Cosmetics; www.djpp.depkumham.go.id 2010, no. 361 3 10. Regulation of the head of the food and drug Supervisory Agency Number HK. 00.05.42.1018 in 2008 about cosmetic ingredients; 11. The regulation of the head of the food and drug Supervisory Agency Number HK. 00.05.42.2995 in 2008 about oversight of Infusion of cosmetics; 12. The regulation of the head of the food and drug Supervisory Agency Number HK. 00.05.1.42.4974 in 2008 about oversight of infusion of cosmetic ingredients; DECIDED: Setting: RULE The HEAD Of FOOD And DRUG WATCHDOG AGENCY ABOUT The OPERATIONAL INSTRUCTIONS MANUAL HOW To MANUFACTURE COSMETICS. First: enact Regulations the head of food and drug Watchdog Agency about the operational Instructions Manual how to Manufacture a good Cosmetic, as referred to in the annex which is part an integral part of this regulation. Second: the cosmetic industry and all parties concerned in all aspects and a series of cosmetic making Operating Instructions refer to the guidelines for Making cosmetics Either as mentioned in the first dictum. Third: this Regulation comes into force from the date of promulgation. www.djpp.depkumham.go.id 2010, no. 361 4 so that everyone knows it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia. Established in Jakarta on June 21, 2010 the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the Republic of INDONESIA, KUSTANTINAH Enacted in Jakarta on July 26, 2010 MINISTER of LAW and HUMAN RIGHTS Republic of INDONESIA, PATRIALIS AKBAR www.djpp.depkumham.go.id 2010, no. 361 5 FOREWORD in accordance with a decision of the head of the Fda RI No. HK. 00.05.4.3870 in 2003 about the guidelines of how to Manufacture the cosmetic is good then to better explain and illustrate the application of the way of making good Cosmetics in the field required Operational Instructions Manual how to Manufacture Cosmetics. Making a good Cosmetic is the basic eligibility requirements, in order that a cosmetics industry able to produce products that are safe, useful and good quality. Besides ASEAN harmonization in the field of cosmetics, then the application of the way of making a good Cosmetic is a priority for the met by a cosmetics industry. To the industry is expected to understand that the application of the way of making a good Cosmetic is a fundamental industry needs to further improve the quality and fresh products, a position that ultimately can strengthen katahanan economy of Indonesia. Therefore, I welcome the publication of the manual of operational guidelines on how to Manufacture Cosmetics with the hope of an increase in the quality and competitiveness of Indonesia cosmetic products in the global market. March 2010 Deputy Field supervision of traditional medicine, cosmetics and products Complement Ruslan Aspan www.djpp.depkumham.go.id 2010, no. 361 6 FOREWORD We are thankful to God that with guidance and ridhoNya, we can complete the Operational Instructions Manual how to Manufacture Cosmetics. Operational Guidelines Manual how to Manufacture cosmetics well done in order the elaboration in detail regarding the application of the way of making good Cosmetics. Operational Guidelines Manual Way of making a good Cosmetic is a reference used by Fda in the Center and Provinces as well as the cosmetics industry in the framework of the application of the way of making good Cosmetics. We realize fully that the operational Guideline Instructions how to Manufacture cosmetics Good is still far from perfect, so the criticism and suggestions to improvement we expect. Hopefully the operational Guidelines Manual Way of making this good Cosmetic benefit the officer and the cosmetic industry in the application of the way of making good Cosmetics. To all those who have participated in the preparation of this Book Award and we sincerely thank you. March 2010 Director of the standardization of traditional medicine, cosmetics and products Complement Hary Rev. T www.djpp.depkumham.go.id 2010, no. 361 7 ATTACHMENT RULES the HEAD of FOOD and DRUG WATCHDOG AGENCY RI number: HK. 03.42.06.10.4556 date: June 21, 2010 OPERATING INSTRUCTIONS MANUAL HOW to MANUFACTURE a GOOD COSMETIC www.djpp.depkumham.go.id 2010, no. 361 8 FOOD and DRUG WATCHDOG AGENCY of the REPUBLIC of INDONESIA 2010 TABLE of CONTENTS FOREWORD..................................................................................... .i INTRODUCTION ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... ii TABLE of CONTENTS ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... iii CHAPTER I INTRODUCTION ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... CHAPTER II GENERAL PROVISIONS 1............................................. 3. CHAPTER III PERSONNEL................................................ 5. CHAPTER IV of the BUILDINGS and facilities........................... 14. CHAPTER V equipment.................................... 23. CHAPTER VI HYGIENE and SANITATION ... ... ... ... ... ... ... ... ... ... ... ... 37. CHAPTER VII production............................................. 64 CHAPTER VIII QUALITY CONTROL............................................................ 97 BAB IX DOKUMENTASI .................................................................... 148. CHAPTER X of INTERNAL AUDITING................................................... 169. CHAPTER XI storage ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 182 CHAPTER XII CONTRACT of PRODUCTION and testing........................ 189 CHAPTERS XIII the HANDLING of COMPLAINTS and the WITHDRAWAL of the product ... ... ... ... ... .... 220 OPERATIONAL PROCEDURES APPENDIX LIST of BAKU (POB)............ iv LIST of ATTACHMENTS WORK INSTRUCTION (IK) ... ... ... ... ... ... ... ... ... ... ... .... vi LIST of ATTACHMENTS note................................... vii LIST of ATTACHMENTS, etc......................................... viii www.djpp.depkumham.go.id


2010, no. 361 9 ANNEX LIST of RAW OPERATING PROCEDURES (POB) number of attachments the attachments Page v. 2: operating procedures Maintenance Equipment Raw ... ... ... ... ... ... ... ... 27 v. 4: Operational Procedures for calibration of raw ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 29 V. 6: Raw Operational Procedures cleaning and Sanitizing Machine Mixer ... ... ... ... .... 31 v. 9: Operational Procedures Raw Calibration Scales with capacity of 70 kg ... 34 VI. 5: the raw application of operating procedures facility's Individual ... ... ... ... ... 44 VI. 9: Operational Procedures of raw Sanitary buildings.................. 51 VI. 11: Raw Operational Procedures cleaning and Disinfection Room Production ... ... ... ... ... ... ... ... ... ... ... ... ... .... VI. 14:54 operating procedures for raw Consumption of pesticides in the production of cosmetic Means.......................................................................... 62 VII. 4: Operational Procedures Baku Reception, storage and delivery of the early Material ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 80 VII. 5: operating procedures of granting Raw Batch/Lot Number ... ... ... ... ... ... ... ... ... ... ... ... .... 81 VII. 9: Raw Processing Procedure Operating Procedure.............. 85 VII. 12: Operational Procedures of packaging Raw ... ... ... ... ... ... ... ... ... ... 89 VII. 1: Operational Procedures of raw Stem Packing Procedure............. 90 VII. 16: Raw Operational Procedures reception, storage and delivery of the finished product....................................................... VII. 93 18: Raw Product Handling Operational Procedures are not appropriate ... ... ... ... ... ... ... 95 VIII. 2: operating procedures and maintenance Tool Usage Raw Pembasuh eye................................ 110 VIII. 4: Operational Procedures Raw calibration of pH meters................... VIII. 112 11: Raw Operational Procedures evaluation and assessment of Suppliers ... ... ... ... 119 VIII. 19: Raw Handling operating procedures Examples Pertinggal ... ... ... ... ... 131 www.djpp.depkumham.go.id 2010, no. 361 10 VIII. 4: Operational Procedures Raw Calibration pH Meter ... ... ... ... ... .... VIII. 112 11: Raw Operational Procedures evaluation and assessment of Suppliers ... ... ... .... 119 VIII. 19: Raw Handling operating procedures Examples Pertinggal................... 131 VIII. 23: Raw operating procedures of handling customer complaints.................... 138.25: Raw Operational Procedure Withdrawing the product..................... 141.26: Operational Procedures of Baku the destruction of Goods ... ... ... ... ... ... ... ... ... ... .... 143 IX. 3: Operational Procedures Document Numbering Raw ... ... ... ... ... 164.4: Operational Procedures Making the operational procedure of Raw Raw ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 166 X 1: Raw Operational Internal Audit Procedures............................. 171 XII. 1: Operational Procedures Contract Production Raw ... ... ... ... ... ... ... ... ... ... ... .... 192 XII. 4: Operational Procedures Baku Contract testing...................... 208 XIII. 1: Raw Complaints Handling Operational Procedures ... ... ... ... ... ... ... ... ... ... .... 223 XIII. 3: the operational Procedures of the raw Product Withdrawal from circulation ... ... ... ... .... 226 www.djpp.depkumham.go.id 2010, no. 361 11 APPENDIX LIST of INSTRUCTIONS (IK) Attachments Attachment Number (example) page i. 1: organizational structure of the plant ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 2 VII. 6: raw material Weighing Instructions ... ... ... ... ... ... ... ... ... .... 82 VIII. 3: Assembly Instructions Respirator For Organic Vapors/acid........................................................ 111 VIII. 5: Instruction Work the use of pH meters............................. 113 VIII. 12: Instruction of work Sampling of raw materials and Packaging Materials ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 121 VIII. 1: Product Sampling Work Instructions Between product and Ruahan ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 124 VIII. 14: Instruction Work Sampling the finished product ... ... ... ... ... ... ... .... 126 VIII. 15: raw material Inspection Instructions ... ... ... ... ... ... ... ... ... ... ... ... .... 127 VIII. 16: Packaging Material Examination Instructions ... ... ... ... ... ... .... 128 VIII. 17: the working Instruction Examination In Process Control (IPC) skin care/hair care/Bath Preparations ... ... 129.22: Instruction of work inspection of finished products, skin care, hair care Preparations, bath......................................... 137 VIII. 24: Instruction Work criteria of customer complaints ... ... ... ... ... ... ... ... .... 139 VIII. 27: Instruction Work the destruction of Goods ... ... ... ... ... ... ... ... ... ... ... ... .... 145 www.djpp.depkumham.go.id 2010, no. 361 12 LIST ATTACHMENT Attachment Attachment Number ENTRY Page III. 4: Individual Records about training the way of making a good Cosmetic ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 13 v. 3: Equipment Maintenance Records............................................... 28 v. 5: records of Calibration and inspection Tools ... ... ... ... ... ... ... ... ... ... ... .... 30 V 7: Record Usage and cleaning Machine Mixer ... ... ... ... ... 32 V 10: records of calibration of the scales with a capacity of 70 Kg ... ... ... 35 v. 11: note the improvement Tools ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 36 VI. 8: note the cleaning of the room ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 50 VI. 10: note the sanitary buildings........................................................ VII. 53 3: Record the receipt of starting material ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... VII. 79 10: Batch Processing Records............................................................ 87 14: VII. Packaging Batch Records.......................................................... 91 VIII. 7: note the manufacture of Reagents And Aqueous Media Breeding ... ... ... ... ... ... ... .... 115 XI. 3: Cosmetic Distribution Records..................................................... 188 www.djpp.depkumham.go.id 2010, no. 361 13 miscellaneous APPENDIX LIST Number Annexes Annex i. Page 1: organizational structure of the plant ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 2.1: description of the post of head of the Department of production................................... 7 III 2: description of the post of head of quality control ... ... ... ... ... ... .... 9.3: Training Program CPKB ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 11 IV. 1: room layout Factory ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 18 IV. 2: types of building materials................................................................ 19 IV. 3: design of Sewer water (longitudinal cross section). 21 IV. Recommendation 4: the power of Light In the room. ... 22 v. 1: Recommendation Tagging Pipeline ... ... ... ... ... ... ... ... ... ... ... ... ... .... 26 v. 8: Label Hygiene equipment........................................... 33 VI. 1: medical examination Program for the Personnel Section production.. ... 40 VI. 2: a State that can be detrimental to the product................................ 41 VI. 3: body armor Suit wearer in Specific Cleanliness Class room with the ... ... ... ... ... ... ... ... ... ... ... ... ... ... 42 VI. 4: Tagging In certain areas that were forbidden......................... 43 VI. Recommendation 6: wash your hands................................................. 46 VI. 7: Room Cleanup Program............................................... 47 VI. 12: Material Recommendations For Disinfecting Sanitation ... ... ... ... ... .... 57 VI. Recommendation 13: the tools to clean Room Production ... ... .... 60 VII. Recommendation 1: the Label/tagging............................................... 76 VII. 2: Materials request form the start............................................ 78 VII. 7: Batch Processing Readiness Checklist ... ... ... ... ... ... .... 83 VII. 8: Checklist for processing Operational before the Cream ... .... 84 www.djpp.depkumham.go.id


2010, no. 361 14 VII. 11: list of Inspection means for Packaging ... ... ... ... ... .... 88 VII. 15: Mail delivery of the finished product.................................................. 92 VII. 17: card stock Products so ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 94 VIII. 1: the layout of the laboratory quality control........................ 109 VIII. 6: Recommendation Status Label equipment..................................... 114.8: Recommendations of the reactant Solution Container Label and Media Label and Breeding Container Solution Titer ... ... ... ... ... ... ... ... .... 116 VIII. 9: Specifications of raw materials and Packaging Materials ... ... ... ... ... ... ... ... 117 VIII. 10: certificate of analysis..................................................................... 118.18: report of an investigation into the failure of Batch ... ... ... ... ... ... ... ... ... ... ... .... 130 VIII.20 : Uji Stabilitas ................................................................................ 134 VIII. 9: test report stability................................................................. 136 VIII. 28: News Events of destruction of goods ... ... ... ... ... ... ... ... ... ... ... ... ... ... 146 VIII. 29: application for destruction of the Goods ... ... ... ... ... ... ... ... ... ... ... ... ... ... 147 IX. 1: level of the document, goals, contents and User document................. 160 IX. 2: types of documents in CPKB.......................................... 163 X 2: Internal Audit Checklist ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 173 X 3: Internal Audit Report.............................................................. 180 XI. 1: raw material Inventory Card................................................... 186 XI. 2: card Supplies the finished product ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 187.2: list of person in charge of activities ... ... ... ... ... ... ... ... ... ... ... ... .... 199 XII. 3: Cosmetic Production Contract Agreement.................................... 200 XII. 5: Cosmetics Testing Contract Agreement................................... 211 XIII. 2: form Report Complaint Cosmetic ... ... ... ... ... ... ... ... ... ... ... ... ... 224 XIII. 4: reports of the withdrawal of the product ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... 228 XIII. Recommendation 5: the destruction of the starting material/product so ... .... 229 www.djpp.depkumham.go.id 2010, no. 361 15 i. INTRODUCTION 1. The background is pretty clear 2. Objective 2.1. General 2.1.1. Pretty obvious 2.1.2. Pretty clear 2.2. Special 2.2.1. Pretty obvious 2.2.2. Clear enough 3. Each company's quality management system should have a vision and mission that demonstrates a commitment to the quality and safety of products are manufactured. Each company must ensure that the cosmetic products produced meet the regulatory requirements of the legislation in force. The company quality assurance system should understand including how to Manufacture Cosmetics (CPKB), and comes with a reliable personnel, buildings, equipment and facilities that are appropriate and sufficient in achieving quality objectives that have been set. Quality assurance covers all matters that can affect the quality of the product, both individually and collectively. It is related to all activities of the company in total to ensure that products that are produced in accordance with quality requirements that have been set. 3.1. Organizational structure of the cosmetic industry listed in Annex i. 1. Authority and management responsibility has been clearly defined. 3.2. Quite clearly 3.3. It is certain that the product has passed review by authorized personnel. Provides an adequate means for ensuring the product is stored, distributed, and handled them well. Perform regular internal audit quality. www.djpp.depkumham.go.id 2010, no. 361 16 Annex i. 1 (example) organizational structure Organizational Structure on cosmetics industry cosmetic industry should be made in such a way that reflects the detachment between the personnel and functions of Parts Production with quality control. The other part is supporting the operational implementation for a factory and when needed can be developed in accordance with the purposes of the factory. QUALITY CONTROL MANAGEMENT PART of the PRODUCTION SECTION of the www.djpp.depkumham.go.id 2010, no. 361 17 II. GENERAL PROVISIONS 1. Internal audit is pretty clear 2. The starting material is quite clear. 3. The raw material is quite clear 4. Packaging Material Packaging material consists of: a. primary packaging Materials namely packaging materials that come into contact with products, among others, such as bottles, tubes and pots. b. secondary packaging Materials packaging materials namely which do not come into contact with the product, among others such as cartons and cardboard. 5. Preservative is quite clear 6. Batch 7 is quite clear. The documentation is pretty clear 8. Pretty clear calibration Note: Calibration of measuring instrument. 9. the Quarantine is quite clear. Batch number 11 is quite clear. Release (released) is quite clear. Making quite clear. Oversight in the process is quite clear. Quality control (Quality Control) is quite clear www.djpp.depkumham.go.id 2010, no. 361 18 15. The packaging is quite clear. The processing is quite clear. Rejection (rejected signal) is quite clear. Products (cosmetics) is quite clear. The production is quite clear. Among the products is quite clear. The finished product is quite clear 22. Product Return (returned) 23 is quite clear. Product Ruahan 24 is quite clear. Sanitation of all efforts made to enhance the cleanliness against means of manufacture, personnel, equipment to ensure conditions that meet health requirements. 25. Material Specification is quite clear. The creation date is quite clear www.djpp.depkumham.go.id 2010, no. 361 19 III. PERSONNEL all personnel must meet the requirements of health, either physical or mental, as well as wearing a clean work clothes. Personnel working in the production area should not diseased skin, an infectious disease or having open cuts, wearing work clothes, hairstyle and appropriate footwear and wear gloves and a mask when needed. Personnel must be available in adequate quantities, have practical experience in accordance with the procedures, processes and equipment. Personnel at the Processing, production and quality control at least educated at least equivalent to the High School Level and above. All personnel must understand the principle of how to Manufacture Cosmetics (CPKB), has a high awareness and attitude to carry it out through periodic and ongoing training. The organisation, qualifications and responsibilities 1.1 clear enough example of the organizational structure of the cosmetic industry listed in Annex i. 1. 1.2 head of Production can be assumed by a pharmacist, Pharmacy Degree, Bachelor of chemical or other personnel who obtain special education in the field of the production of cosmetics and have experience and skills in leadership so as to allow carrying out duties as a professional. Head of Production be independent, have the authority and full responsibility for managing the production of cosmetic covers operational tasks of production, equipment, personnel, documentation and production area. 1.3 head of quality control can be assumed by a pharmacist, Pharmacy Degree, Bachelor of chemical or other personnel who obtain special education in the field of quality control of cosmetic products. Quality control Section head should have full authority and responsibility in all aspects of quality control of such preparation, verification and application of quality control procedures and has the Authority (if needed) personnel to check-pointing, passed and rejected the starting materials, products, product ruahan between, and a finished product that is made in accordance with the procedures established and approved. 1.4 Description of tasks that includes responsibilities and authorities of each of the core personnel ("Key Personnel") as head of production, quality control Section Head, head of engineering and head of the Department of human resources should be clearly defined and specified. Description the Office of the head of Production is listed on Appendix III. 1 Description the Office of the head of the quality control Section is listed on Appendix III. 2. the 1.5 clear enough www.djpp.depkumham.go.id


2010, no. 361 20 Training 2.1. The core personnel should know, understand and never received training on good CPKB held the authorities (e.g.: Agency/Large Hall POM) or the Association. The core personnel to plan and create a training program as well as play an active role in training CPKB. 2.2 2.2.1 Training Program. Training increased knowledge about CPKB given to personnel who are directly involved in the activities of the manufacture of cosmetic products. 2.2.2. Special training should be provided to personnel who work with hazardous and toxic materials. 2.2.3. the training Program is provided on an ongoing basis at least once a year to ensure that personnel are familiar with the requirements of the task-related CPKB. 2.2.4. Training should be done according to a written program that has been approved by the head of production and quality control Section Head or or other related Parts. 2.2.5. CPKB Training can be given by superiors are concerned, experts or by coach from outside the company. 2.2.6. Training materials can be either publicly CPKB introduction to all personnel at the plant and materials specific to certain sections, e.g. Part production or quality control. Examples of training programs is listed on Appendix III CPKB. 3. 2.3. To know the success of the training should be evaluated include: 2.3.1. CPKB knowledge thoroughly and in particular in accordance with his duties, respectively. 2.3.2. Assessment of training personnel. Training already carried out should be noted. Individual Training record CPKB be made in accordance with the field of duty respectively which includes: 2.3.2.1. Date of training. dusky Name personnel who attend training. 2.3.2.3. The name of the instructor, part or institutions that provide training. 2.3.2.4. Training materials and tools being used. 2.3.2.5. Demonstration is done, if any. 2.3.2.6. Evaluation of trainees. Examples of Individual Notes about training CPKB listed on Appendix III. 4. 2.3.3. Assessment of personnel behavior three months after training CPKB performed assessment of the behavior of every personnel in carrying out her work fits CPKB. www.djpp.depkumham.go.id 2010, no. 361 21 Appendix III. 1 (example) DESCRIPTION of the OFFICE of the HEAD of PRODUCTION Office Task Description position: head of Production: production reporting to: Director oversees the Warehouse Supervisor:-raw materials-Processing Supervisor-Packaging-Supervisor Supervisor Warehouse finished product 1. Knowledge and ability a head Section can be assumed by a pharmacist or other personnel, have knowledge and experience in the field of the manufacture of cosmetics, planning and control of production, knowledge of machines, CPKB and untiring leadership. 2. Description of tasks in General Production Section Head responsible for ensuring the manufacture of cosmetics, in order to meet the requirements of the cosmetic quality defined and created with attention to implementation CPKB, within the time limit and the production costs. 3. The scope of duties and responsibilities 3.1. Regulate the planning and control of production to meet customer demand so that the stock of raw materials or finished products balanced according to company policies. 3.2. Leading and directing subordinates in all implementation of the processing and packaging, both technically as well as administration. 3.3. Improving the effectiveness and efficiency of production. 3.4. Establish a work network with related government agencies. 2.2. Evaluating the results of the work of the production section, make improvements continuously and make monthly reports. 3.6. Responsible for ensuring the manufacture of cosmetic products which meet the requirements of quality has been established, ranging from packaging, processing, weighing up to delivery to the warehouse of finished products. www.djpp.depkumham.go.id 2010, no. 361 22 Advanced 3.1. Responsible for the availability of raw operating procedures (POB) on the production. 3.2. Responsible for checking records of Batch Processing and Batch Packaging Records as well as a guarantee that all stages of production is carried out in accordance with the processing and Packing POB POB. 3.3. Accountable so that proper equipment and production machinery design, right size, used correctly and secure clean. 3.4. Is responsible for the cleanliness of production throughout the area. 3.5. Is responsible for the development and training of employees, maintain discipline, maintain motivation and perform an evaluation against the employees of his retainers. 1. Authority: 4.1. Add and subtract the number of employees, mutation and promotion on the part of the production in accordance with his needs with the approval of the Director. 4.2. Create Production Section annual budget with the approval of the Director and to conduct surveillance of implementation of the budget. 4.3. Request and or approve the procurement of production facilities and infrastructure in accordance with company policies and procedures that apply. 4.4. To approve, modify or repair the POB in parts production. …………… TGL............. 20. ... ... Have read and understand Cc to: 1. Director 2. Head of Personnel Section 3. In question 4. Archive (..................) Head of production of www.djpp.depkumham.go.id 2010, no. 361 23 Appendix III. Example 2 DESCRIPTION the OFFICE of the HEAD of the QUALITY CONTROL Office Tasks Description position: head of section: quality control quality control reporting to: Director Includes: Chemical Physics Laboratory Supervisor Supervisor Microbiology Laboratory Inspektor 1. The knowledge and ability of the head of the quality control can be assumed by a pharmacist or other personnel, have knowledge and experience in the field of quality control of cosmetics, knowledge of laboratory equipment, CPKB and untiring leadership. 2. Description of tasks in general quality control Section Head responsible for provided the quality of cosmetics are manufactured according the quality requirements specified by the company and standard CPKB. Its main task is to establish the status of the specification, the starting materials, products, product ruahan and between finished products in accordance with predetermined specifications and following up complaints of consumers. 3. The scope of duties and responsibilities 3.1. Supervise the implementation of all the POB is has been executed correctly in accordance with the provisions made. 3.2. Analysing the production failure, discuss it with related parts as well as the search for the causes and workarounds. 3.3. Evaluate and establish stability products/ingredients and set the standard in accordance with the existing data. 3.4. Establish a work network with related government agencies. 3.5. Create periodic reports and other reports requested by the supervisor or other parts. 3.6. Responsible for the availability of specifications and testing methods of starting materials, products, ruahan products, between the finished product as well as supervision during the production process of POB. 2.3. Is responsible for the planning and execution of the entire quality control Section activities include the implementation of tasks in physics laboratory chemistry, microbiology, implementation of the supervision during the production process. www.djpp.depkumham.go.id 2010, no. 361 24 Advanced 3.1. Responsible for passing a decision or reject the starting materials. 3.2. Responsible for passing decisions, reject, or reprocess the products are manufactured or stop the production process when needed. 3.3. Responsible for checking records of Batch Processing and Batch Packaging Records. 3.4. Is responsible for the development and training of employees, maintain discipline, nurture, motivate and evaluate employees against his subordinates. 1. Authority 4.1. Add and subtract the number of employees, the mutation and promotion on the part of the quality control in accordance with their needs with the approval of the head of the factory. 4.2. Create quality control part of the annual budget with the approval of the head of the factory and to conduct surveillance of the implementation of the budget. 4.3. Request and or approve procurement and infrastructure quality control in accordance with company policies and procedures that apply. 4.4. To approve, modify or repair the POB in parts quality control. 4.5. Emend POB. 4.6. Propose the recall of products from circulation based on the results of testing the quality of the sample pertinggal or instruction authorized agencies. …………… TGL............. 20 ... Have read and understand Cc to: 1. Head 2. Head of Personnel Section 3. In question 4. Archive (.......... ……) Head of quality control www.djpp.depkumham.go.id


2010, no. 361 25 CPKB TRAINING PROGRAM page 1 of 2 MATERIALS PARTICIPANTS TRAINERS TRAINING METHODS/TOOLS ASSESSMENT METHOD of SCHEDULE i. TRAINING in GENERAL 1. The general orientation of 1.1. Company Introduction 1.1.1. 1.1.2. Company history 1.1.3 organizational structure. The company's code of conduct 1.2. 1.3. Product Introduction A detailed description of the duties of their respective personnel 1.4. Introduction to the place of work, toilets, cafeteria and traffic are allowed for all General oral Explanation Section personnel started to go work the Oral Question 2. CPKB basics 2.1. Specificity of cosmetic factory new personnel Trainer CPKB/Supervisor concerned a lecture/presentation audio visual questions before work started to go after training & 2.2. Personal hygiene: 2.2.1. The necessity of wearing work clothes and work equipment, such as masks, gloves, headgear, footwear 2.2.2. The need for hand washing before work 2.2.3. Personnel who are sick and have open wounds may not work in cosmetic 2.2.4 processing. Knowledge of microbial bacteria especially regarding & how do I prevent all personnel Trainer CPKB/Supervisor concerned Lectures/audio visual presentation once a year the question before the bacteria did not practice after & breed 2. 3. General cleanliness 2.3.1. The need for custom work with clothing and equipment/machines that clean all personnel Trainer CPKB/Supervisor concerned Lectures/audio visual presentation once a year the question before & www.djpp.depkumham.go.id training after 2010, no. 361 26 Advanced MATERIAL PARTICIPANTS COACH TRAINING METHODS/TOOLS SCHEDULE ASSESSMENT METHODS 1. Safety and health of work 3.1. First aid training on specified Personnel Accident Coach K3/trainer CPKB/Supervisor concerned Lectures/audio visual presentation/demonstration started to get work and once a year a demonstration/implementation of direct observation in the workplace 3.2. Handling hazardous materials Waste (B3) all personnel related government agencies CPKB/trainer/Supervisor concerned Lectures/audio visual presentation once a year Ditto 3.3. Tackling the fire hazard all personnel Trainer/coach K3 CPKB/Supervisor concerned Lectures/audio visual presentation/demonstration once a year Ditto 2.1. Safety all personnel K3 Coach/trainer CPKB/Supervisor concerned a lecture/presentation audio visual/peragaan every 6-12 months Ditto II. TRAINING SPECIFICALLY 1. The general orientation of 1.1. An explanation of the specificity of a particular part of the work in, e.g. Banning personnel wear jewelry, watches, fake lashes and make up excessive space in the production personnel in the corresponding section of the superior concerned Lectures/audio visual presentation started to get work & once a year a written oral Question & 1.2. An explanation of the use of certain personnel in the relevant section of the relevant Supervisor/Technician on-site Explanation/demonstration started to get work once a year an oral Question & & demonstration 2. Training at work 2.1. Practice implementing POB 2.2. Exercise regarding the procedures for entering the space production 2.3. Exercises on how to use certain tools in the Personnel Section in question concerned the Employer's explanation on the spot/demonstration started to get work & once a year a demonstration/implementation of direct observation in place III. ADDITIONAL TRAINING 1. Explanation if there is a good rule change regarding CPKB, POB, new tools and new products at the Personnel concerned Coach CPKB/technician/Supervisor concerned Explanation in place/show when there are changes of the oral Questions or written & demonstration 2. Evaluate the errors that have occurred and how to overcome it personnel in the section in question concerned the Employer's explanation and demonstration of the Oral Question error when there is a written & www.djpp.depkumham.go.id 2010, no. 361 27 Appendix III. 4 (example) INDIVIDUAL RECORDS ABOUT TRAINING the WAY of MAKING a GOOD INDIVIDUAL RECORD COSMETICS ABOUT TRAINING CPKB name:......................................................... TANGGAL LAHIR : ......................................................... GENDER: MALE/FEMALE *) START WORKING:......................................................... PREVIOUS JOB: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... Assessment of Coach Material date SIGNATURE description of the concerned Personnel Supervisor Chief General/Hr *) choke on unnecessary www.djpp.depkumham.go.id 2010, no. 361 28 IV. BUILDINGS and FACILITIES 1. The location should be selected flood free, away from the landfills, not in crowded residential place, avoid the pollution and does not pollute the environment. If it is not possible to do so precluded precautions against contamination, for example: Media Pollutants/Pest precautions the air Dust roads, dust particles, another industry, the pesticide completes the ventilation system with the right air filter Former middens, pesticides and chemicals-construction building sturdy and waterproof Non-seepage of water from the ground water-seepage of water through the soil and hard water-flood-water containing colloidal-microbial pathogens-are equipped with the drain water is effective. -Ground water must pass through the initial filtration such as sand filters, chlorination and other treatment, such as deionisasi etc. Building-Insects, rodents, birds and other animals-the installation of a wire gauze on the Windows and vents-installation of plastic door curtain-Extermination of insects-insect Trap Building should meet the requirements of appropriate regulations applicable to construction such as Building Permit (IMB), the necessary infrastructure and facilities including means of security. Efforts need to be made to prevent impurities to the surrounding environment. In case of leakage or spilling raw material/product ruahan should be dilokalisir so as not to extend. 2. Building for the production of cosmetics should be separate from the building for the production of other products such as medicines or traditional medicine. The supply of household health products that do not contain harmful substances (non-hazardous), e.g. liquid hand SOAP, can be produced in one building but with a special treatment in order to prevent cross-contamination and the risk of mixed diffuse, i.e. by doing the cleaning, maintenance and checking of the means/tools on each turn of the production including production scheduling in turns. 3. to prevent the occurrence of cross-contamination, the production of powder should be done in a separate room equipped with control dust (dust collector). www.djpp.depkumham.go.id 2010, no. 361 29 manufacture of products that burn easily, such as aerosol products should be done in the space of processing that is placed on a separate building and have systems of protection against fire hazard or an explosion. For the production of high levels of alcoholic products and nail polish, if the building does not allow a separation then taken precautions and safeguards against the danger of fire or explosion. 4. Dressing Room be separated from processing space with a space between. It is also a means must be provided for storing clothes/shoes/footwear/bags and goods – goods are private property. The door of the washroom (toilet) may not be directly related to the production area, equipped with a water sprayer or a shower, wash your hands and tools with a hot air dryer, tissue paper or towels clean and dry. Small rooms for men and women should be separated. Noted a warning sign, that any personnel must wash hands with SOAP/detergent after using the restroom. Wash hands, should: 4.1. Placed on the required place, for example in the locker room clothing. 4.2. Equipped with faucets, SOAP or detergent and dryer with hot air or towel dry and clean as well as the trash bertutup. Minimum number of toilets are recommended based on the number of personnel are: number of Personnel the number of toilets required 1 – 15 1-2 16 35 2 36 55 3 56 – – – 80 4 81 – 110 6 > 150 PEOPLE Plus 1 for each additional 40 personnel 5. Tata-spaces be designed in accordance with the acceptance of the goods flow and the flow of the production process in order to prevent the occurrence of the risk of errors, mix-ups and cross-contamination of the product. Be provided sufficient for the area: www.djpp.depkumham.go.id


2010, no. 361 30 5.1. The reception of raw materials and packaging materials 5.2. Quarantine of raw materials and packaging materials 5.3. Sampling of raw materials and materials packaging 3.4. Storage of raw materials and materials packaging 3.4. Weighing 5.6. Mixing or processing of 5.7. Washing tool 5.8. NET tool storage 5.9. Among the products and product storage ruahan 5.10. The primary packaging of 5.11. Secondary packaging 5.12. 5.13 finished product quarantine. Storage and delivery of finished products 5.14. Laboratory production Areas should not be used as general traffic for personnel who do not work in the room. Let the created a corridor for traffic personnel where every space of production can be achieved without having to go through more production space. The plant room layout examples listed in Annex IV 1. 6. The surfaces of floors, walls, ceiling and doors let: 6.1. Waterproof 6.2. There is no connection to reduce the release of or the collection of particles. If it is inevitable to be made a special procedure for pembersihannya. 6.3. Easy to clean and resistant to cleaning materials and or disinfectant. For production areas should be avoided the use of material from wood. If you use material from wood for the final layer, e.g. oil-based paint. The meeting between the floors, walls and ceilings let arch-shaped for easy cleaning. Examples of the types of building materials are listed in Appendix IV. 2. 7. Quite clearly. Design of drainage are listed in Appendix IV. 3. 8. Installation of the Airways and other pipe installations should be installed such that it is easy care and cleaning, e.g. above the ceiling of the corridor or indoors and given enough distance with a wall to avoid the build-up of dust and for easy cleaning. 9. Each activity requires a certain intensity lighting. 9.1 Recommendations Power light bulbs in the Room listed in Appendix IV. 4. 9.2 9.2.1 Temperature Control and Ventilation. Ventilation of the room be arranged so that the exchange of air can eliminate steam, gas, smoke, odors and dust and heat production badly. www.djpp.depkumham.go.id 2010, no. 361 31 9.2.2. Ventilation holes be equipped with filters that can prevent the entry of insects or dust air into the room and easy to clean. 9.2.3. If needed, then let temperature regulator works properly to be able to prevent the pollution produced by air flowing. 9.3 For spaces controlled processing (material of the baby and preparations around the eyes), installed an air control system equipped filters, including temperature and humidity control, which works well to prevent pollution particles and microbes of product through the air flowing into the room. For products of the powder must be equipped with a dust collector. 10. Installation of the lights in the area of processing and packaging be flat to the ceiling and bertutup. Stop electrical contact be made flat to the wall surface for easy clean up. Power cable for machine processing should come from sources of electricity above the ceiling or from a residing along the corridor space processing. 11. Pretty obvious. 12. Pretty obvious. www.djpp.depkumham.go.id 2010, no. 361 32 Appendix IV. 1 (example) ROOM LAYOUT FACTORY www.djpp.depkumham.go.id 2010, no. 361 33 Appendix IV. 2 (example) TYPE of BUILDING MATERIALS SURFACE in DIFFERENT BUILDINGS DESCRIPTION CORRESPONDS to 1. Solid Concrete FLOOR a. a. Are holding dust b. is not resistant to spills of chemical solution is used only in the area of warehouse b. Concrete coated vinyl sheet a. resistance to chemicals limited b. Connection welded so that the watertight c. Easily scratched d. For imposition are offices, corridors and Labs c. Epoxy or polyurethane a. Monolithic, the surface is not porous and not slippery b. Restrain bacterial growth c. Easily scratched the production Room d. a. ceramic tiles are resistant to chemicals and scratches b. Easy repaired c. Requires closing the gap d. Connection difficult to cleaned Area production of cement Tiles of e. a. Economical and easily repaired loophole closure Requires b. c. d sanitized hard Connection. Do not spill chemicals resistant e. is not resistant to scratches and 2 Offices. Brick walls or concrete blocks, solid surface is smooth plastered and made watertight with a layer of oil paint, paint from acrylic materials or enamel high polymers, polyurethane or epoxy. a. easily cracked when the work was less well b. Raises dust when disassembled for repair or renovation. The area of production of www.djpp.depkumham.go.id 2010, no. 361 34 Advanced SURFACE in DIFFERENT BUILDINGS DESCRIPTION CORRESPONDS to 3. A. ceiling concrete painted with oil paint, acrylic, enamel material of high polymer or epoxy a. Difficult modified for the installation of power lines and air duct b. designed to withstand heavy burden c. Room on it can be used for the placement of the Airways and other service Areas of processing and charging cable type Panel b. (made from gypsum, plywood coated with enamel) a. Need steel cantilever b. could not resist the heavy burden c. Connection needs to be closed with a silicone rubber for the prevention of pollution from the space on top production Area www.djpp.depkumham.go.id 2010, no. 361 35 Appendix IV. 3 (example) DESIGN of SEWER water (longitudinal cross section) of the floor water Traps of the stainless steel body of steel grating with a stainless steel lid bersekrup connection to the disposal of www.djpp.depkumham.go.id 2010, no. 361 36 Appendix IV. RECOMMENDATION 4 POWER LIGHT Power Light INDOORS (units of Lux) Activity 20 Corridors narrow, alley 50 Warehouses for large containers , a corridor for traffic corridors of 100 people for the traffic of people and forklifts, break room, dressing room, toilet room, ancillary means, stairs, reception room, Workshop shed 200 300 500 Office, laboratory, production room, first aid room on accident (first aid) 750 image space 1000 visual Inspection Note: 1 foot candle (flc) = 1 lumen/foot2 (lm/ft2) = 10.764 lux light Power measured using the Luxmeter www.djpp.depkumham.go.id 2010 No. 361 37 v. EQUIPMENT the equipment used in the manufacture of cosmetics should have the right architecture, the size is adequate and in accordance with the desired batch size. The equipment should not react with the ingredients/products, easy to clean/disanitasi and placed in the right location, so that guaranteed security and uniformity of the resulting product quality as well as safe for personnel to operate. 1. Architecture 1.1. An example of a material that does not react or absorbing materials, among other stainless steel type AISI 316, 316 L. 1.2. Quite clearly. 1.3. All parts of the equipment must be affordable, easily disassembled and reassembled and no part that can withstand the rest of product or cleaning materials and sanitation. 1.4. Is quite clear. 2. Installation and placement of 2.1. Installation and placement of equipment/machinery should consider the smooth traffic of goods and people over the stages of the production process; the distance between the equipment with one another not to interfere with the process of production; ensure cross-contamination does not occur; How to simplify maintenance, cleaning and sanitation; To avoid contamination of other products, as well as protect the health of personnel, equipment that can give rise to dust during the production process, is placed on a separate room and is equipped with a vacuum cleaner. For the manufacture of baby products and products around the eyes, the equipment used should be given special attention especially to the microbial impurities and placed in a room that has been disinfected beforehand. 2.2. System plumbing drains, steam, pressurized air and vacuum: 2.2.1. Must be equipped with faucets that can be operated easily. 2.2.2. Must be equipped with a gauge calibrated or verified the truth and accuracy of their functions. 2.2.3. It should not be planted to facilitate cleaning and maintenance. 2.2.4. Given the designation of different colors and a clear direction of flow. 2.2.5. Strived not to form an angle that makes it difficult for the cleaning process. Recommendation Tagging drain pipes listed in annex v. 1. 2.3. The accuracy of the functioning of all ancillary systems must be calibrated on a regular basis especially for measuring instrument which affects the quality of the product. www.djpp.depkumham.go.id


2010, no. 361 38 Electrical Installations should be installed in such a way that is easily reached during ongoing production activity and avoid the occurrence of accidents. 3.-maintenance 3.1. For the calibration process, let the set of operational procedures of Baku (POB) equipped with calibration period. 3.1.1 Appropriateness kalibrator used should have been verified by the Certification Body that is recognized, when not available, the calibration process can be performed by a recognized agency. 3.1.2 Results calibration be recorded and kept for a period specified in POB. Examples of Equipment Maintenance POB listed in Appendix v. 2 Record Maintenance Equipment Examples listed in Annex v. 3 Example POB for calibration are listed in Appendix v. 4. Example Note Calibration and inspection Tools are listed on Annex v. 5 3.2. Pretty obvious 3.2.1 POB cleaning and sanitizing any equipment be proven reliability. 3.2.2 POB must: 3.2.2.1. ensure that no equipment left behind the rest of the products are manufactured in advance and the rest of the cleaning materials; 3.2.2.2. equipment guarantee free of materials used for sanitation; 3.2.2.3. made on any changes to the products that will be produced or any complete production process. 3.2.3 the equipment already cleaned labelled ' clean '. 3.2.4 the Label ' clean ' should list the time and name of the executors who did the cleaning process, as well as the time the validity status of the tool. 3.2.5 Sanitation be conducted periodically or if there is contamination of bacteria or fungus on the results of the output product (product between, ruahan products or finished products). Examples of POB cleaning and Sanitizing Machine Mixer are listed on Annex v. 6. Examples of the usage Entry and cleaning Machine Mixer are listed on Annex v. 7. Example of Label Hygiene Equipment listed in Annex v. 8. Example of Calibration of the scales with a capacity of POB 70 Kg are listed in Appendix v. 9. The example Records the calibration of the scales with a capacity of 70 Kg are listed in Appendix V. 10. Example Note repair tool are listed in Appendix V. 11. www.djpp.depkumham.go.id 2010, no. 361 39 Annex v. 1 TAGGING PIPELINE BASIC COLORS COLORS for letters/TAGGING pressurized water vapor pressurized Air red black Orange Black vacuum (vacuum) Black Yellow gray Nitrogen Gas oxygen Gas light blue Black Black Black Green LPG Gas CO2 Purple Black White Black Water distilled Water demineral Water Black light green ground/black and white firefighters for www.djpp.depkumham.go.id 2010 No. 361 40 Appendix v. 2 (example) of RAW OPERATING PROCEDURES MAINTENANCE EQUIPMENT page 1 of 1 RAW OPERATING PROCEDURES MAINTENANCE EQUIPMENT number ... ... ... ... .... N A M A COMPANY ... ... ... ... ... ... ... ... ... .... PART.................... Sexy....................... Effective date........................... Compiled by ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... Review by........................ Date ... ... ... ... ... ... ... ... ... .... Approved by........................ Date ... ... ... ... ... ... ... ... Replace the number ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... Objective: to obtain the appropriate equipment maintenance ditetapakan standards. Tools for milling Machine a. b. Machines sift the Powder Charger Machine c. d. electronic equipment Methods: based on the specifications of each tool Name Tool Parameters observed Description 1. Machine Milled a. ban driving each morning review b. lubrication/oil every 1 week plus oil, oil changed every 6 months c. Hammer beater Every 1 month replaced d. strainer Every 1 month replaced 2. The machines sift a. lubricant/oil/Vaseline food grade Every 2 weeks, every 3 months plus replaced b. belt movers Every month examined c. wheel gilas Every 1 month replaced d. leaf fan separator every 3 month review/repositioned 3. Machine Filler Powders mechanical treatment of: a.-cleaning of the sealer, the granting of the grease and the oil cleaned up every day with a copper brush, given the oil on the hinge lugs. vet-charging once a week filled vet on the part that is mounted vetnipple b. Electronic Treatments:-violence bolts and nuts every day cleaning of the dust-checked every day cleaned www.djpp.depkumham.go.id 2010, no. 361 41 Annex v. 3 (example) RECORD MAINTENANCE EQUIPMENT company name.......................................... NOTE MAINTENANCE TOOL Implemented according Number POB:.................................... Tanggal: .................................... THE NAME OF THE TOOL: ... ... ... ... TYPE/BRAND:................... ROOM: ... ... ... ... ... ... ... .... IMPLEMENTATION Of MAINTENANCE CHECKS Start Finish NO. TYPE of WORK Hours Date Date Date hours by Hours Both Hours Description maintenance and inspection carried out in accordance with the POB number ... .. dates ... ... .... www.djpp.depkumham.go.id 2010, no. 361 42 Annex v. 4 (example) of RAW OPERATING PROCEDURES for CALIBRATION of N A M A company ... ... ... ... ... ... ... ... ... .... RAW OPERATING PROCEDURES for CALIBRATION of 1 Page number ... ... ... ... .... PART.................... Sexy....................... Effective date........................... Compiled by ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... Review by........................ Date ... ... ... ... ... ... ... ... ... .... Approved by........................ Date ... ... ... ... ... ... ... ... Replace the number ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... The goal: to get the right tool according to specifications so that it can support the process analysis and quality control. Tools a. each tool can be calibrated Standard calibration solution b. c. standard child scales method: based on the specifications of each tool Name Tool calibrated parameters Calibration of analytical Scales reset Internal weight: periodically once a week or according to the frequency of usage. External: minimum 1 year all other weight scales are Internal: periodically once a week or according to the frequency of usage. External: at least 1 years pH-meter pH Each before use www.djpp.depkumham.go.id 2010, no. 361 43 Annex v. 5 (example) NOTE the CALIBRATION and INSPECTION TOOL company name................................................ CALIBRATION AND INSPECTION TOOLS ... ... .... Implemented in accordance Number POB:................................. Tanggal: ................................ Observations Are Appropriate Procedures Eligible Date. The parameter RESULT yes no performed by the Supervisor Notes **) Notes: • note the improvements performed in calibration or inspection results are not eligible. • Perform calibration reset after the tool has improved. www.djpp.depkumham.go.id 2010, no. 361 44 Annex v. 6 (example) of RAW OPERATING PROCEDURES CLEANING and SANITIZING MACHINE MIXER page 1 of 1 RAW OPERATIONAL PROCEDURES CLEANING and SANITIZING MACHINE MIXER number ... ... ... ... .... N A M A COMPANY ... ... ... ... ... ... ... ... ... ... ... ... .... PART......................... Sexy...................... Effective date........................... Compiled by ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... Review by........................ Date ... ... ... ... ... ... ... ... ... .... Approved by........................ Date ... ... ... ... ... ... ... ... Replace the number ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... 1. Objective: to get the mixer engine always clean so free of materials that are used on the previous batch. 2. Attention: 2.1. Mixer machine should always be cleaned after completion is used not to happen and will stain that is difficult to clean. 2.2. Cleaning the machine must be carried out immediately after the visible label "INSTRUCTION to CLEAN UP". 2.3. After completion of the cleaning, the machine is "clean" label affixed and immediately reported to the supervisor to do the examination. 3. Cleaning materials used: clean water Aquadest Alcohol 70% chemicals steam cleaners hot 4. Purifier 4.1. Wipe dry the wet laps not fibrous/4.2. Engine vacuum cleaner 5. A place to clean up: space production cream 6. Implementation of cleaning: using a vacuum cleaner machine, all parts in the machine mixer mixer blade and cleaned including the sidelines inside until the remains of the missing entirely and clean ingredients, then the wet washcloth with dilap and subsequent dilap with dry rag. Rinse with alcohol 70%, after dry and clean, attach the label "clean" and report it to the supervisor for an examination of the level of cleanliness. www.djpp.depkumham.go.id 2010, no. 361 45 Annex V. 7 (example) NOTE the USE and CLEANING of the MIXER MACHINE company name................................................ NOTE the USE and CLEANING of the MIXER ENGINE carried out according the number POB:....................... Tanggal: ..................................... THE NAME OF THE TOOL: ... ... ... .... TYPE/BRAND:.............. ROOM: ... ... ... ... ... .... The USE Of CLEANSING Started Finished Started Finished No. Date Hours Of PRODUCTION No. Batch Date Hour By Hour Date Date Hour Ket. Cleaning and inspection carried out in accordance with the POB number ... .. dates ... ... .... www.djpp.depkumham.go.id


2010, no. 361 46 Annex V. 8 (example) LABEL HYGIENE EQUIPMENT company name............................................................... T E L A H D I B E R S I H A N K A L A T: ... ... ... ... ... ... .... IDENTIFICATION NUMBER: ... ... ... ... ... .... ROOM: ... ... ... ... ... ... ... .... CLEARED BY:................................ Date:.................................... At: ... ... ... ... ... ... ... ... ... ... ... ... ... .... USED FOR:................................... Product: ... ... ... ... ... ... ... ... ... ... BATCH NUMBER: ... ... ... ... ... ... ... ... ... .... EXAMINED AND WAS DECLARED CLEAN BY:................................... Date:.............................. www.djpp.depkumham.go.id 2010, no. 361 47 Appendix v. 9 (example) OPERATIONAL PROCEDURES for the RAW CALIBRATION SCALES with CAPACITY of 70 KG page 1 of 1 the OPERATIONAL PROCEDURE of RAW CALIBRATION SCALES with CAPACITY of 70 KG number ... ... ... ... .... THE COMPANY'S NAME.............................. PART.................... Sexy.................... Effective date........................... Compiled by ... ... ... ... ... ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... ... ... ... ... ... ... ... .... Review by................... Date ... ... ... ... ... .... Approved by................. Date ... ... ... ... ... ... Replace the number ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... 1. Objective: to get the accuracy of a device according to the specifications that have been determined. 2. Implementers: Officer Weighing 3. Work procedures: 3.1 Check zero point; the needle pointer or numbers should show zeros. 3.2 Put children most standard light scales, see the needle pointer or specified. Repeat weighing it with heavier weights. Child standard scales used: 10 kg, 20 kg, 25 kg, 70 kg. 3.3 calibration results Noted this in the notes of the scales calibration scales. 3.4 Make conclusion of the calibration results. The scales are considered works well when the weight is indicated by the tool scales do not stray more than 0.1% of the weight of each child standard scales used. www.djpp.depkumham.go.id 2010, no. 361 48 Annex V 10 (example) NOTE the CALIBRATION of the SCALES with a CAPACITY of 70 KG company name................................ SEKSI ……………………………………………….. RECORDS of the CALIBRATION of the SCALES with a CAPACITY of 70 KG name............................... Models.......................... Capacity ... ... ... .... Functions.............................. Identification Numbers.............. Location ... ... ... .... Dates used: ... ... ... ... ... ... ... .... CALIBRATION and INSPECTION carried out in accordance with the POB ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Nomor: ............................................ Tanggal : ................................ Standard scales Limits child 1. 10.000 kg (9.990-10.010) kg 2. 20.000 kg (19.980 – 20.020) kg 3. 40.000 kg (39.960 – 40.040) kg 4. 70.000 kg (69.930 – 70.070) kg-Weigh Child Date an 10 kg Meme-nuhi Terms (yes/no) Children Weigh 20 kg 90s Meme-nuhi Terms (yes/no) Child Weigh 40 kg-an ordered nuhi Terms (yes/no) Child Weigh-an 70 kg Meme-nuhi Terms (yes/no) Ket. Paraf 4.01.05 9.995 Yes Yes Yes 39.980 20.000 69.950 Yes Good Note any repairs performed in the inspection/calibration results are not eligible. Do a restart calibration after repair was completed. www.djpp.depkumham.go.id 2010, no. 361 49 Annex V. 11 (example) NOTE REPAIR TOOL company name................................. NOTE: TOOL NAME TOOL REPAIRS ... ... ... ... ... ... ... ... .... TYPE/BRAND:........................... ROOM: ... ... ... ... ... ... ... ... DAMAGE REPAIR CHECKS Start Finish No Date On the processing time of the product, No. batch type of damage By Date Date Date Clock Hours By hours of Good not good parts checked www.djpp.depkumham.go.id 2010, no. 361 50 VI. SANITATION and HYGIENE and Sanitation of facility aims to eliminate all potential sources of contamination and cross-contamination in all areas that could be at risk on the quality of the product. The scope of the sanitation and hygiene covers personnel, buildings, equipment and supplies, starting material, environment, sanitation and cleaning materials. Cleaning and sanitation is a major consideration at the time of designing the buildings and equipment in a cosmetic factory. A good cleanup has a very important role to produce a product with high quality and low costs (efficiently). Implementation of the cleanup can be divided into three kinds, namely: 1. The Cleansing routine (Housekeeping cleaning). 2. Cleansing with a more thorough use of sanitation and cleaning materials aid (Deep cleaning). 3. Cleansing in order maintenance (cleaning and Maintenance). 1. Human resources 1.1. All personnel should undergo a medical examination before being accepted as well as during the work. Medical examination be carried out periodically for any personnel involved in the production process as well as to serve in the laboratory. Examples of medical examination Program for the production section of the Personnel listed in Appendix VI. 1. 1.2. All personnel that direct contact with the product during the work must comply with the hygiene rules in such a way so as to protect the product from contamination. Personal hygiene such as hand washing should be done before going into production, after the area of the toilet, after eating and smoking, as well as wearing work clothes and protective instruments more appropriate place/area they work as noted in the operational procedures of Baku (POB) in Appendix VI. 5. 1.3. Is quite clear. 1.4. Is quite clear. Examples of circumstances that may be detrimental to the Products listed in Appendix VI. 2. 1.5. To avoid direct contact with the product, personnel should use gloves and other necessary tools. To protect the product from contamination and ensure the security of personnel, let yourself wear the protective clothing the body clean, cover the hair, masks, goggles, earplugs and footwear that fits the task undertaken. Personnel may not wear jewelry (rings, watches, studs, etc.), false eyelashes and exaggerated facial makeup on while working in space. www.djpp.depkumham.go.id 2010, no. 361 51 examples of body armor Suit Wearer in the room with a certain Hygiene Classes listed in Appendix VI. 3. 1.6. The recommendation is quite clear Labelling on certain areas that are prohibited are listed in Appendix VI. 4 1.1. Everyone who enters the area of production, both for the personnel who worked fixed or temporary, as well as for personnel who did not serve in the area of production but the production area such as personnel administration, contractors, visitors, staff/leadership of the company and the inspector should apply Individual Hygiene including POB wearing protective clothing. Examples of the application of Individual Hygiene POB listed in Appendix VI. 5. An example hand wash Recommendation listed in Appendix VI. 6. 2. Building 2.1. Water supply and sanitation activities for plumbing must be ascertained enough, doesn't leak and clean for the cleaning and sanitation activities. listed in chapter IV of the grains 4 2.2. Is quite clear. listed in chapter IV of the grains 4 2.3. Is quite clear. 2.4. Be made of sanitary building POB outlining the schedule, methods, equipment, cleaning materials, sanitary materials, rodentisida, insecticides and fungicides that are used as well as the name of the person in charge of the implementation of sanitation. Example of indoor Cleanup Program listed in Appendix VI. 7. The example Records the cleaning of the room is listed on Appendix VI. 8. Example Sanitary Buildings are listed on the POB Appendix VI. 9. Example Note Sanitation Buildings listed in Appendix VI. 10. Examples of POB cleaning and disinfection of the production Room listed on Appendix VI. 11. Examples of Recommendations For Disinfecting Sanitation Materials listed in Appendix VI. 12. Example Recommendation tools to clean Room Production listed in Appendix VI. 13. Examples of the usage of pesticides in POB Means Cosmetic Production are listed in Appendix VI. 14. 3. Equipment and supplies 3.1. Is quite clear. Listed on the attachment of the labels are clean. 3.2. Quite clearly. www.djpp.depkumham.go.id 2010, no. 361 52 3.3. Let the cleaning and sanitation POB made equipment/Fixtures schedule, outlining the methods, tools and materials used and the method of disassembling and assembling back equipment when needed. POB cleaning and Sanitation be re-examined periodically to ensure that the procedure is still effective and meets the requirements. Note the implementation of cleaning and sanitation be created and saved. Appendix VI. 1 (example) MEDICAL EXAMINATION PROGRAM for the PERSONNEL PRODUCTION SECTION of the TYPE of MEDICAL EXAMINATION Before being accepted to work each year After recovering from a severe infectious disease 1. General examination 2. X-ray examination 3. Examination of feces, urine and blood 4. Examination of the respiratory tract √ √ √ √ √ if necessary when necessary when necessary √ if necessary when necessary when necessary www.djpp.depkumham.go.id


2010, no. 361 53 Appendix VI. 2 (example) STATE that CAN HARM the PRODUCT Case example 1. A. a means of unclean or dirty. b. the contamination by a material that has nothing to do with the production are being carried out. c. a leak on a pipeline. 2. a. Equipment is likely to damage the machine begins with a small symptom happens but not yet clearly visible. b. faulty Installation but not cause damage to the machine. c. Discharging equipment that has not been cleaned. 3. Personnel a. implementation of production does not match CPKB. b. a deliberate Mistake or accident which are not reported by the perpetrators of the misconduct. c. other personnel Reported being exposed to infectious diseases or suffer a wound. www.djpp.depkumham.go.id 2010, no. 361 54 Annex VI. 3 (example) BODY ARMOR SUIT WEARER in SPECIFIC CLEANLINESS CLASS ROOM with the KIND of UNIFORM USAGE of BODY ARMOR and OTHER REQUIREMENTS in the ROOM with the CLEANLINESS CLASS 1. Clothes Replaced 2 or 3 times per week or when dirty. 2. Special work Shoes. 3. Protective hair Replaced 2 or 3 times per week or when dirty. 4. Cover the mouth of the Wear on the dusty materials processing, at the time of the open handle. Changed daily 5. Gloves used in processing by hand. Made from rubber. Replaced when dirty www.djpp.depkumham.go.id 2010, no. 361 55 Appendix VI. 4 TAGGING on SPECIFIC AREAS that are PROHIBITED PROHIBITED PROHIBITED SMOKING PROHIBITED EATING DRINKING www.djpp.depkumham.go.id 2010, no. 361 56 Annex VI. 5 OPERATING PROCEDURES (example) the RAW APPLICATION of FACILITY'S INDIVIDUAL page 1 of 2 OPERATING PROCEDURES APPLICATION of INDIVIDUAL HYGIENE RAW number ... ... ... ... ... ... N A M A COMPANY ... ... ... ... ... ... ... ... .... BAGIAN ............................ SEKSI ............................... Effective date............................ Compiled by ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... Review by........................ Date ... ... ... ... ... ... ... ... Approved by........................... Date ... ... ... ... ... ... ... ... ... Replace the number ... ... ... ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... ... ... ... ... ... .... I. INTRODUCTION the cosmetics are generally used to maintain the appearance and cleanliness. Therefore cosmetics should be attempted in order to be free from any kind of pollution. One source of pollution is the skin's own human/tubuh that brings a lot of microorganisms. II. Hygiene PROVISIONS, the individual should be carried out by any person residing in the employee's & area productions, including guest, managing technical maintenance and repair, management staff. III. APPLICATION of the FACILITY'S INDIVIDUAL everyone involved in the production process should apply the principle of individual hygiene which include: 1. Health 1.1. Not allowed to work in the production process if: 1.1.1. Have open wounds, itchy spots, ulcers or skin disease. 1.1.2. Contracted infectious diseases on the upper respiratory tract, cold, cough, allergy pollen. Employees who suffered from the disease should be reported to his superiors to immediately do further security measures. 1.2. Do the medical examination periodically. 1.3. after recovery from infectious diseases be held appropriate health screening to determine eligibility to work. 1.4. Supervision should be done against infectious disease symptoms on employees who work on the production. www.djpp.depkumham.go.id 2010, no. 361 57 page 2 of 2 the OPERATIONAL PROCEDURES of the RAW APPLICATION of FACILITY'S INDIVIDUAL number ... ... ... ... ... N A M A COMPANY ... ... ... ... ... ... ... ... .... BAGIAN ........................... SEKSI ............................ Effective date............................ Compiled by ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... Review by.......................... Date ... ... ... ... ... ... ... ... ... ... .... Approved by......................... Date ... ... ... ... ... ... ... .... Replace the number ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... ... ... 2. Personal Hygiene 2.1. Everyone should carry out individual kebersihaan habits. 2.2. Bathe regularly every day. 2.3. regular hand-washing among others after urination or defecation. Be held regarding the use of SOAP and how the use of hand-washing facility. 2.4. The hair should be kept in order to be always clean and tidy. 2.5. Prohibited combing hair in the production room. 2.6. It is prohibited to wear earrings, necklaces and other jewellery. 2.7. The wearing of cosmetics be slightly possible. 2.8. It is prohibited to wear false eyelashes and a variety of beauty helpers can fall into the product. 3. The Customs Hygienic 3.1. Banned chewing, eating and drinking in the space production and laboratory. 3.2. It is prohibited to smoke in the laboratory and production space. The sign "no smoking" should be installed at the entrance and in the important places. 3.3. Cleanliness and regularity of work space should always be kept. 3.4. The room should be cleaned immediately before starting the work of another kind. 3.5. Wardrobe should be kept in order to be always clean and tidy. 4. Clean Clean Clothes Clothing used both to protect production against implementing the products and product against implementers. 4.1 any person who is in the region of production should wear clean protective clothing and special designed and provided for the purpose. 4.2 clean work clothes and protective gear such as hats, gloves should wear extra protective clothing such as masks and protective glasses. 4.3 work clothes must not be used outside the factory. 4.4 work clothes should always clean. 4.5 work clothes should be worn exactly as it should be. 4.6 work clothes should not have pockets above the waist. www.djpp.depkumham.go.id 2010, no. 361 58 Appendix VI. 6 (example) HAND WASH RECOMMENDATION 1. Wash your hands with SOAP or use a solution of detergent. When you need to nail brushed with brush that is already available and put SOAP or detergents that are available. 2. Hand then rinsed with enough water until the SOAP does not feel the presence of residual or detergent. 3. after washed, hand-dried with disposable washcloth or another type of a washcloth clean and dry or with a penghembus warm air at a temperature of 0-60 32 0 c, the speed of hembusnya is strong enough. 4. after dry, the hands do not touch objects that may be littering. If there is a way, hand washing should be repeated again. www.djpp.depkumham.go.id 2010, no. 361 59 Annex VI. 7 (example) INDOOR CLEANUP PROGRAM INDOOR CLEANUP PROGRAM page 1 of 3 names/objects being cleaned Cleaning vacuum clean the tool with the right with a wet wipe Clean with a wet rag and disinfectant cleanse with brush Ket. WEIGH ROOM, processing & PACKAGING 1. The floor every day and when necessary at work every day after work is completed and when necessary at work once a week using a detergent, then wipe moistened with disinfectant 2. The walls of the room every day after the porcelain finish is used once a week 3. Lights, ceiling once a week 4. Windows, Gaps per day 5. Wardrobe, desk, Chair, the handle of the door every day after the production once a week 1. Wash hands, wash the Tools Every day every day every day 6. Recycle Bin once a week ago with a detergent cleaned with a rag moistened with disinfectant www.djpp.depkumham.go.id 2010, no. 361 60 INDOOR CLEANUP PROGRAM page 2 of 3 names/objects being cleaned with a cleaning powder right Cleaning Cleaning vacuum Cleaning tool with kan kan with a wet wipe Clean with a wet rag and disinfectant Cleaning brush with REST ROOM right 1. The floor twice a day once a week wearing a wet rag and then detergent disinfectant 2. Porcelain wall once a week 3. Cabinets, tables, chairs a week twice 4. Window, door every day SMALL ROOMS (TOILET) 1. The floor every day if necessary at work once a week wearing detergent then wipe moistened with disinfectant 2. Closet every day 3. Close the closet every day 4. Porcelain wall once a week 5. The door, the handle of the door every day 6. Place hand-washing twice a day 7. Sewer water every day www.djpp.depkumham.go.id 2010, no. 361 61 INDOOR CLEANUP PROGRAM page 3 of 3 names/objects being cleaned Cleaning vacuum clean the tool with the right with a wet wipe Clean with a wet rag and disinfectant cleanse with brush Ket. LOCKER ROOM 1. The floor twice a day once a week using a detergent, then wipe moistened with disinfectant 2. Walls once a week a CORRIDOR 1. Daily floor finish production and when necessary on work hours a day twice a week once by using a detergent, then wipe moistened with disinfectant 2. Porcelain wall once a week www.djpp.depkumham.go.id 2010, no. 361 62 Appendix VI. 8 (example) NOTE the CLEANING ROOM Date Implementing the results of Implementing the results of the Date www.djpp.depkumham.go.id


2010, no. 361 63 Annex VI. 9 OPERATIONAL PROCEDURES (example) RAW SANITARY BUILDING page 1 of 2 RAW SANITARY OPERATING PROCEDURES BUILDING company name........................................ BAGIAN .......................... SEKSI ................................. Number ... ... ... ... ... ... Effective date............................ Compiled by ... ... ... ... ... ... ... ... ... ... ... ... .... Tanggal ....................................... Review by............................ Tanggal .................................... Approved by............................ Tanggal .................................... Replace The Number ... ... ... ... ... ... ... ... ... .... Tanggal ..................................... I. purpose of Sanitation of the building aims to reduce the microbial population in order for cosmetic means of production and means of its surroundings have the appropriate hygiene levels in order to support the production of qualified cosmetic quality. II. Implementing and in charge of 1. Sanitation of buildings carried out by the implementing of sanitation. 2. in the tasks and responsibilities of the implementing Sanitation report to head of engineering. 3. the head of the quality control inspection schedules set the level of cleanliness and contacted the head of the Engineering Section if found results that do not qualify. 4. the head of the Department of production Engineering Section Head contact if, after the implementation of sanitation in the production room and beyond the level of hygiene achieved is not eligible. III. Sanitation sanitation Solution Solution that can be used, among others: 1. Ethyl alcohol 95% 2. Ethyl alcohol 70% aqua solution 3. Isopropyl alcohol full strength 4. Isopropyl alcohol 70% aqua solution 5. Formalin 3.75 cc/m2 Note:-solution of sanitation should be replaced once a month-sanitary solution is kept is no more than a week. IV. Implementation of Sanitation 1. Clean the floor with a vacuum cleaner at least once a day. Dipel with antiseptic solution and sprayed using the sanitizer. Do not use a broom, because it will cause dust and dirt fly into the cosmetics are manufactured. www.djpp.depkumham.go.id 2010, no. 361 64 page 2 of 2 the OPERATIONAL PROCEDURE of RAW SANITARY BUILDING company name............................... BAGIAN ................................ SEKSI ................................. The number ... ……………… Effective date............................ Compiled by ... ... ... ... ... ... ... ... Tanggal ............................... Review by........................ Tanggal ............................... Approved by......................... Tanggal ................................. Replace The Number ... ... ... ... ... ... ... ... ... ... Tanggal ................................... 2. Remove the dirt from the bottom of the equipment, in the corners and on the spot is difficult. This would exclude supplies of food for the pests as well as maintaining the cleanliness of the area of the building. 3. Clean and sanitary the surface of work desk. Pathogenic bacteria may be present on the surface and can be carried away into cosmetics. 4. set the air pressure, temperature, humidity and filters that are appropriate. Frequently clean the filter and pipes. A clean filter will prolong the "exhaust fan", because it does not have to work too hard. 5. Get rid of goods that are unused. 6. Provide a covered trash cans outdoors. 7. Wash and sanitary containers and tank before use. This will reduce the spread of pathogenic microorganisms. 8. Clean the toilets, lockers and changing rooms at least once a day. 9. To provide hot water and cold water flows and SOAP in the dispenser for hand memcuci. Use the hand dryer or towel dry and clean to dry. 10. To prevent contamination, and it should come with an automatic cover. I. pest control 1. Eliminate a place to nest with equipment that is not used as well as maintain cleanliness in all areas, especially in the back of the equipment. Caring for floors and walls with good nesting places to eliminate. 2. Prevent pest entry by installing screens on Windows and doors. 3. fill holes around pipes and drainage. 4. check the goods it can against a possible bite rodents or cockroaches die etc. 5. Elimination of the sources of water and food for the pests. 6. use a pest control company has permission. 7. Rodentisida, insecticides and fumigation materials not polluting packaging, raw materials, ruahan as well as the finished product. 8. Prevent contamination caused by the toxic bait, which should be labeled poison. 9. the dead Pests should be immediately removed. 10. Waste should be stored in air-tight containers against pest and hygiene areas should be maintained. www.djpp.depkumham.go.id 2010, no. 361 65 Annex VI. 10 (example) BUILDING SANITATION RECORD Date Implementing the results of Implementing www.djpp.depkumham.go.id Results 2010 Date, no. 361 66 Appendix VI. 11 OPERATIONAL PROCEDURES (example) CLEANSING and DISINFECTION of the ROOM RAW PRODUCTION page 1 of 3 RAW OPERATIONAL PROCEDURES CLEANING and DISINFECTION ROOM PRODUCTION company name....................................... BAGIAN ................................. SEKSI ................................... Number ... ... ... ... ... ... ... Effective date......................... Compiled by ... ... ... ... ... ... ... ... Tanggal ............................... Review by........................ Tanggal ............................... Approved by......................... Tanggal ................................. Replace The Number ... ... ... ... ... ... ... ... ... Tanggal ................................. 1. The purpose of the building for the production of cosmetics should be cleaned and disinfected on a regular basis and as required in order to: 1.1. Preserved in an environment that is clean and safe. 1.2. Dust and dirt is removed because it is a barrier against the quality of cosmetics production and implementation. 1.3. Reduce the risk of impurities cross between different products that are made using the same room and/or equipment are the same. 1.4. Reducing pollution by microorganisms. 2. Materials 2.1. The water was not always adequate disinfection and cleaning materials as, so for the purposes of the required material and disinfectant cleaners. 2.2. Cleaning materials are materials used to remove dirt from the surface of an object. 2.3. Description of the specific uses of cleaning materials must be obtained from the factory original poster and should be evaluated before it was decided to use. 2.4. When possible, use liquid cleaning materials always. Cleaning materials shaped powder particle impurities would cause. 2.5. Example of cleaning materials as listed in the table below: No. The name of the Ingredient Levels used Usage 1. Instructor sulfonat detergents, alcohol ether and alcohol sulfonat etoksilat 0.1% v/v multi purpose for equipment, floors and glass 2. Anionic detergents and liquid types of sodium alkilsulfat 1% v/v tank and container used for liquid cosmetic processing 3. SOAP or liquid soap To wash your hands and tools 4. Other detergents to taste the outer surface of the tank, glass goods, equipment from stainless steel, small rooms and flooring www.djpp.depkumham.go.id 2010, no. 361 67 2.1. Disinfection is the process of destruction of the microbial cells, but cannot remove/damage the spores. 2.1.1. Disinfectant should be selected according to its use based on an examination of its potential in microbiology or information from the manufacturer. 2.1.2. Disinfectant used should correspond to the surface of the object it will be disinfected and the tools that will be used for implementation of the disinfection 2.1.3. It must be ensured that the disinfectant does not cause corrosion or discoloration of the floor, the surface of metal tools or painted. 2.1.4. To look for information regarding the formulasinya makers and possible impact on health. 2.1.5. It is recommended that the use of two or more successive disinfectant each during a certain time to prevent microbial resistance. Disinfectant replacement should have a chemical structure and anti microbial properties of different work. 2.1.6. Example of the disinfectant as shown in the table below: 2.2. An antiseptic is used on living tissue (e.g. skin) to kill micro-organisms or inhibit its growth. Page 2 of 3 RAW OPERATIONAL PROCEDURES CLEANING and DISINFECTION ROOM PRODUCTION company name................................ SEXY PART Number ... ... ... ... ... ... ... Effective date......................... Compiled by ... ... ... ... ... ... ... ... Tanggal ............................... Review by........................ Tanggal ............................... Approved by......................... Tanggal ................................. Replace The Number ... ... ... ... ... ... ... ... ... Tanggal ................................. No. The NAME of the MATERIAL USED and the CONSUMPTION LEVELS of DESCRIPTION 1. Klorheksidin gluconate and Setrimid 2.5% a. floor, arms and equipment for the processing of aseptis. b. the Power of his work have been hampered by the SOAP and detergent anionic. c. Power decreases if the contact works with plastic, cotton MOP and hard water. 2.5% Cresol Floor 3. Isopropyl Alcohol 70% of equipment and surface 4. Formaldehyde gas Form a. Fumigation processing aseptis area. b. the pungent odor piercing are sporisidal. 5. Sodium hypochlorite 0.1 – 1% a. Surface-surface. b. be able to scrape stainless steel. www.djpp.depkumham.go.id


2010, no. 361 68 page 3 of 3 RAW OPERATING PROCEDURES CLEANING and DISINFECTION ROOM PRODUCTION company name................................ BAGIAN ..................................... SEKSI ................................. Number ... ... ... ... ... ... ... Effective date......................... Compiled by ... ... ... ... ... ... ... ... Tanggal ............................... Review by........................ Tanggal ............................... Approved by......................... Tanggal ................................. Replace The Number ... ... ... ... ... ... ... ... ... Tanggal ................................. 2. Security 2.1. Cleaning materials and disinfectant should be handled carefully because it is a powerful and dangerous materials. Usage instructions of the manufacturer must be observed/followed well. 2.2. use of tools such as protective gloves, aprons, protective glasses, safety shoes at the time working with these materials. 2.3. Cleaning materials and disinfecting generally should not be used in the mix, because there is the possibility to react chemically and poses a danger. 2.4. A disinfectant containing alcohol or other flammable solvents should be stored and handled in particular. 2.5. Material cleaners or disinfecting do not replaced by others before it is certain that the substitute materials have the same safety and effectiveness with the materials used previously. 3. The use of material and disinfectant Cleaner 3.1. Disinfecting generally available in the form of a solution of concentrated and must be diluted according to the instructions of the manufacturer. The dilution should be in accordance with the provisions and note. You shall not make any further dilution for its use. 3.2. Dilution should be done using clean water. The use of hard water should be avoided because they can lose their effectiveness. 3.3. Disinfecting and cleaning materials must be diluted immediately before use. 3.4. Solution of sanitizer and disinfectant solution should be disposed of unused and their vessels are washed every day after finished use. 3.5. do not mix disinfecting which have different chemical structures with sanitizers, as can reduce work power anti microbial drastically. 4. the provisions on cleansing and disinfection of POB. 4.1. There should be a POB about every way of cleaning and disinfection. The procedure should be written in language that is easily understandable by implementers of cleaning and disinfection. 4.2. The procedure should include the following in detail: 4.2.1. The area or room should be cleaned and disinfected. 4.2.2. the Surface should be cleaned and disinfected. 4.2.3. The schedule of cleaning and disinfection. 4.2.4. Types of materials used, the concentration used and way of use. 4.2.5. The schedule of exchanges use of disinfection. 4.3. the Procedures must be approved by the head of quality control. 4.4. The procedure should not be modified without the knowledge of the person in charge of cleanliness including in charge of quality control. www.djpp.depkumham.go.id 2010, no. 361 69 Appendix VI. 12 (example) RECOMMENDATIONS for DISINFECTING SANITATION MATERIAL things. 1 of 3 INFLUENCE on DISCHARGING NO NAME MATERIAL CONCENTRATION USED (%) The WORKINGS of the PROFIT LOSSES of 1. Ethanol 70 Denaturation proteins and enzymes. React fast, evaporates without leaving any residual, have cleaning power. Accelerate the formation of rust, flammable, may cause irritation to the eyes. 2. Goals. phenol 0 – 90 Denaturation of proteins and enzymes. Bactericide, disinfecting power are not affected by hard water and organic matter. Irritating to the skin and mucous membranes, smell, can not be merged with alkaline, not acidic cleaners who succeed to. 3. Goals. Aldehyde-Formalin-Glutaraldehida 3 – 5 2% solution in water solution encompasses plus sodium bicarbonate. Denaturation of proteins and enzymes. Formaldehyde is not corrosive towards metals. Glutaraldehida can be merged with the detergent, but on some surface forming a yellow film. Toxic, it smells pungent are irritation of the respiratory tract, eyes and skin. Corrosive nature of glutaraldehyde against stainless steel containing carbon www.djpp.depkumham.go.id 2010, no. 361 70 thing. 2 of 3 INFLUENCE on DISCHARGING NO NAME MATERIAL CONCENTRATION USED (%) The WORKINGS of the PROFIT LOSSES of 4. Iodium and Iodium 75 – 150 CPM (ppm) Oxidants React fast, there is already a concentration of influence in the small, chemically stable, non-irritant to the skin, their penetration power both Are corrosive, coloring and damaging some types of plastics and clothing, not unified with anionic detergents, is irritation of the eyes 5. Goals. peroxide: hydrogen peroxide Oxidizing 5-7 do not leave residue Not unified with some detergent, is corrosive to some metals, damaging the rubber, plastics and clothing, easily decomposes to oxygen and water 6. Chlorine compounds:-Kloramin-Hypochlorite 1-4 Are spacious Are bactericidal Oxidizing irritant to skin, eyes and lungs, corrosive to some metals, damaging the rubber, plastics and clothing, not unified with some detergent. www.djpp.depkumham.go.id 2010, no. 361 71 things. 3 of 3 INFLUENCE on DISCHARGING NO NAME MATERIAL CONCENTRATION USED (%) The WORKINGS of the PROFIT LOSSES of 7. Their three-dimensional ammonium compounds 1-6 outlines the proteins and enzymes, interfere with the integrity of the cell membrane Is a good cleanser, can still function if there is organic material and hard water, is a good deodorant, stable, not corrosive towards metals. Causes irritation, some compounds can damage the eyes, not unified with anion compounds 8. Ethylene oxide Alkylation at the compound required in the metabolic reactions Have good penetration power against a porous fibrous materials and Require strict supervision on the usage, leaving the rest of which are toxic, before worn remains of ethylene oxide must be removed from the materials processed www.djpp.depkumham.go.id 2010, no. 361 72 Annex VI. 13 (example) RECOMMENDATION tools to CLEAN ROOM PRODUCTION Introduction the tools and materials used to clean depending on the type of production that is carried out in the room and the type of room that will be cleaned up. Based on the type of doping that occurred in a room, the cleaning Procedures were underway as well as determined the equipment used to carry out the procedure. POB provides information about tools and materials that are commonly used to clean room production is not sterile. The tools used to clean room production, as listed in the table below: NO HOW to USE TOOL USED on/description 1. Cloth rag or foam (sponges), must be the kind that absorbs and does not release the fibers or color substances Dampen with cold water or warm water and wipe on the surface that will be cleaned up, if it is sufficient to absorb the dirt, rinse with cold water or warm water until clean, proceed with the cleaning of 1.1. The surface of the furniture is 1.2. The surface of the equipment that is not greasy. Wall Description: 1.1. Cloth rag or foam that is out of date is replaced with a new 1.2. Store in a dry state 2. Floor cleaning tools with fabric or foam and stalk the holder made of metal or plastic, preferably don't use sprigs of wood 2 .. 1 Moisten with water or a disinfectant solution for pengepelan 2 .. 2 Squeeze to taste by using squeeze 2 .. 3 Mop the floor with the tool 2 .. 4 MOP or foam should be frequently cleaned during pengepelan. Floor Description: 2.1 Should be provided 2 buckets each containing water or a disinfectant solution for pengepelan and water for cleaning Water that has begun 2.2 dirty should be replaced with a new www.djpp.depkumham.go.id


2010, no. 73, NO. 361 advanced TOOLS HOW to USE USE on/description 3. The equipment consists of a stalk with a MOP or foam, one or two buckets for a container a solution of pengepelan and solution of pembilas, above the runway and wheel squeeze 3.1. Rinse and wash off in water that is placed in a bucket and wring it out to taste special pembilas 3.2. Moisten with water or a disinfectant solution for pengepelan 3.3. Squeeze to taste by using squeeze 3.4. Continue with pengepelan and cleansing according the above way Description: Water for cleaning the floor that has begun is dirty should be replaced with new ones. 4. floor cleaning tool consisting of:-the broom Part mechanical spin on the cleaned floor surfaces-cleaning solution and Container holds his life direction and dead Manager cleanup tool-can be equipped with liquid on the floor of 4.1. The contents of the container cleaning solution with a solution of detergent 4.2. Turn on the pengepel floor machine especially towards the stained or sticky and point cleaning tool as appropriate cleansing 4.3. Already cleaned floor will be wet MOP with a tool called pengepel on grain b on the floor, mainly to clean up the grime stuck firmly on the floor Description: by using this tool, it will terpercik cleaning solution onto the floor and surrounding area cleaning 5. Tool or bottle atomizer bottle with Contents cleaning solution cleaning solution, spray the cleaned and dry it with a cloth rag or foam glass, doors and so on. Description: the bottle to put cleaning solution are usually made from plastic and spray in the direction that will be cleaned up. Note: do not use a broom and a feather duster as it can spread the dust to another place at the time of cleaning. www.djpp.depkumham.go.id 2010, no. 361 74 Appendix VI. 14 (example) PESTICIDE USAGE RAW OPERATIONAL PROCEDURES in COSMETIC PRODUCTION MEANS page 1 of 2 OPERATIONAL PROCEDURES for RAW CONSUMPTION of PESTICIDES in the PRODUCTION of COSMETIC MEANS number ... ... ... ... ... ... .... THE COMPANY'S NAME............................. PART............................. Sexy...................... Date ... ... ... ... Compiled by ... ... ... ... ... ... ... ... ... .... Tanggal ............................. Review by........................... Tanggal ................................... Approved by........................... Tanggal ................................... Replace The Number ... ... ... ... ... ... ... .... Tanggal ............................... 1. Pesticides Registered Pesticides that can be used are registered and approved the circulation, marketing as well as its use by the Government. 2. Types of Usage of this type of usage, appropriate usage of pesticides are grouped as follows: 2.1. Sprayed in cracks and cavities in the production area and outside the production area 2 .. 2 Sprayed automatically as the fog outside the region of production. 2 .. 3 are regularly used in the form of fog outside the region of production and at any given time is used in indoor production. 2.4 Used on the underground without arising to the surface. 2 .. 5 Sprayed around the outside of the building. 2.6 sprinkled on the soil around the outside of the building. 2.7 is placed on the tray or container the bait outside the region of production. 2.8 Fumigation (fogging). 3. General provisions 3.1. The use of pesticides is limited to spraying cracks and cavities that are on the perimeter of the area of production. 3.2. How the fog and the bait is restricted its use for Office, hallway, break room, warehouse and production area is not that there is an open product. 3.3. Spraying conducted in cracks and cavities in the area rather than production. 3.4. The ground and round the outside of the building can be sprayed or sprinkled pesticide dry. 3.5. Use of pesticides that deviate from the defaults: 3.5.1. Changing the concentration of pesticides that is recommended on the labels 3.5.2. Deviating from the Schedule applicable to 3.5.3. Use the fog in the area of production of 3.5.4. Spray the areas production without limit it in cracks or cavities in it. www.djpp.depkumham.go.id 2010, no. 361 75 company name............................ PESTICIDE USAGE RAW OPERATIONAL PROCEDURES in COSMETIC PRODUCTION MEANS page 2 of 2 number ... ... ... ... ... ... .... PART.............................. Sexy........................... Date ... ... ... ... Compiled by ... ... ... ... ... ... ... ... ... .... Tanggal ............................. Review by........................... Tanggal ................................... Approved by........................... Tanggal ................................... Replace The Number ... ... ... ... ... ... ... ... ... ... .... Tanggal ............................... 3.5.5 All other activities related to the use of pesticides that are not pengawasannya procedures outlined in a written way, use of POB aforesaid must first be approved by the person in charge quality control. 3.10 the Supervisory Procedures should consider: 3.6.1 certainty that pests can be destroyed or controlled 3.6.2 not polluting Pesticides cosmetic products or the surface related to cosmetic products 2.3 Fogging and the use of bait should be restricted at the Office, corridor, warehouse or other non production spaces where products are not directly exposed. 2.4 should be made regarding the documentation of income, consumption and residual pesticides are stored and the name of the authorized user. 2.4 storage of pesticides should be supervised in order to prevented the occurrence of mix-mixer with a raw material or finished product. 3.10 Before pesticides are used in a room, let the officers in the room before checking out the room and hold a prevention or safeguards as necessary so that the pollution did not happen against the finished product. The results of the examination should be documented. 3.11 execution of pesticide use should be supervised person that was authorized by the quality control. When pesticides are used, factory officials should ensure that implementers read, understand and follow the instructions printed on the POB is concerned. 3.12 Let done recording the date, time and manner of the use of pesticides, the area that is covered and materials used, the number of procedures being followed, signed executor and supervisor concerned. 3.13 in contractual agreements implementing pesticide use should be listed that are used are simply materials that sanctioned its use by Governments and every time it is used in accordance with applicable government regulations and POB are concerned. www.djpp.depkumham.go.id 2010, no. 361 76 VII. The PRODUCTION of 1. 1.1 starting material. Water 1.1.1 Water is one of the main raw materials in the cosmetics industry. Therefore air should get special attention both in the manufacture, storage or distribution. 1.1.2 water sources can be obtained from: 1.1.2.1 1.1.2.1.1 groundwater (wells). clean water treatment Company 1.1.2.1.2. 1.1.2.2 Be provided clean water according to applicable standards. 1.1.2.3 the water from these two sources above should be further processed to be used in the production process. 1.1.2.4 Washing and sanitizing equipment used in water processing system, shall be carried out on a regular basis with an Operational Procedure Baku (POB.) This is intended to prevent the occurrence of contamination that can affect water quality. The selection of sanitary ways very depending on the type of installation and can be done using hot steam (steam) or chemical materials. When used in a chemical material shall be attempted so that the rest of the chemical ingredients are not left behind in the water at the time will be used. 1.1.2.5 1.1.2.5.1 water quality for the products: specifications and the quality of water to be used depending on the allocation, namely: 1.1.2.5.1.1 at least the quality of drinking water in accordance with national standards of raw products, such as shampoos, conditioners, soaps. 1.1.2.5.1.2 pure water quality by the standards of Pharmacopoeia for product inventory and preparations around the eyes. 1.1.2.5.2 for cleaning/washing: water quality need not be level with water to the production process. 1.1.2.5.3 For flushing the end: must use the same water quality by water to the production process. www.djpp.depkumham.go.id


2010, no. 341 77 1.1.2.5.4 For sanitizing: hot water vapour. 1.1.2.5.5 the complete water quality Examination should be done periodically according POB. Let this be done also examination of water each to be used, for example organoleptis/description, pH, and conductivity as well as for monitoring logging should be done. This examination can be performed alone or with external laboratories. 1.1.2.5.6 storage tank Cleanup and piping systems is carried out at regular intervals in accordance with the POB. Any irregularities occurred against the existing system, should immediately actionable and do correction and prevention. 1.1.2.5.7 specific to the parameters of the routine examination done in microbiology, quantitative and qualitative. 1.1.3 1.1.3.1 water treatment Methods known to several levels of manufacturing pure water for production: 1.1.3.1.1 pre-disinfection (e.g. by chlorination), flocculation/coagulation (e.g. aluminium). 1.1.3.1.2 Screening/filtration using multimedia filters (gravel-sand-carbon) up to size 10 micron filtering sieve with the back, size 2 micron. 1.1.3.1.3 hardness Removal (softening column). 1.1.3.1.4 Deionisasi/demineralisasi this system can be either a series of resin cation exchanger resin anion exchanger, or a combination of a resin cation and anion exchanger (mixed beds). 1.1.3.1.5 distillation System is carried out by means of heating and condensation of water vapor. 1.1.3.1.6 "Reversed Osmosis" (RO) is done using a semi permeable membrane. 1.1.3.1.7 Ultra Violet System. 1.1.3.2 the storage and distribution of water to be taken care of properly. Water that is not disirkulasi should be used no more than 24 hours. 1.1.4 Water piping systems 1.1.4.1 piping systems be made of appropriate materials such as stainless steel so that it does not allow the release of ingredients that are not desirable, for example ion of iron. www.djpp.depkumham.go.id 2010, no. 361 78 1.1.4.2 piping systems should be made in such a way that it didn't happen a stagnation of the water (dead leg/dead end) or leaks that can lead to the occurrence of contaminants by microbes. piping System 1.1.4.3 is made such that it is easily washed and disanitasi periodically according POB, either with chemicals or with using steam of hot water or steam. 1.2. Verification of the material Any starting materials must have clear specifications. 1.2.1 in terms of security, consistency and expediency of all starting materials should supply: 1.2.1.1 Verified physically: 1.2.1.1.1 identity of suppliers. 1.2.1.1.2 type and amount of packaging. 1.2.1.1.3 packaging Conditions (leaking, damaged, dirty, and others). 1.2.1.1.4 availability of the certificate of analysis from the manufacturer starting material. 1.2.1.2 Quarantined, soon after the arrival to the sanctioned for use in the production process. 1.2.1.3 was given the designation of identity/status on any packaging material early in order to facilitate tracking up to the finished product. 1.2.2 Against starting materials which have been received, carried out: 1.2.2.1 sampling for the purposes of the examination of compliance with quality specifications. The number of examples taken should correspond to the purposes of the examination based on the analysis of procedures for each type of material, as well as represent of the total ingredients. 1.2.2.2 Assignment status (rejected or passed) based on the results of the inspection. Release or rejection must be made in writing and communicated to the related sections, such as production, purchasing, logistics and so on. Given a token release or rejection is physically on the packaging of such materials and are recorded on the system documents are used. 1.2.3 starting materials received must have a label of identity and a clear status labels. Can also be given security label, label, label-recommended handling storage, information about protective tools that should be used and so on. The label must not cover the original starting material identity label. 1.2.3.1 Label identity contains among others: 1.2.3.1.1 product name. product code number 1.2.3.1.2. Batch Number 1.2.3.1.3. Product Number 1.2.3.1.4. 1.2.3.1.5 Date receipt of starting material. 1.2.3.1.6 the name of the supplier. Expiration Date 1.2.3.1.7 ingredients (if any). Paraf 1.2.3.1.8 receiver. www.djpp.depkumham.go.id 2010, no. 361 79 1.2.3.2 Label status States: 1.2.3.2.1 Sanctioned/rejected/quarantine. 1.2.3.2.2 the date of sampling. Release Date 1.2.3.2.3/rejection. 1.2.3.2.4 signature/paraf Part quality control. 1.2.3.2.5 the date of the test. The identity and status of the label can be in one label. Examples of Labels/Labelling Recommendations listed in Annex VII 1. 1.2.4 at the time of receipt of starting material, during storage and after the use of starting materials, containers should always clean and well-covered. 1.2.4.1 must be ascertained there are no containers damaged, leaking, contaminated, perforated, exposed or mixed with other ingredients. 1.2.4.2 when found damaged or leaking containers or mismatch of materials with the document, must be immediately reported to get follow-up. 1.2.4.3 Containers starting materials must be cleaned prior to entry into the quarantine warehouse, to production, to the weighing and before it is returned to the warehouse after weighing. 1.3. Recording Materials all materials accepted 1.3.1 should have a full entry as follows: 1.3.1.1 Name starting materials. 1.3.1.2 Name manufacturer starting material. 1.3.1.3 Name suppliers. 1.3.1.4 date of acceptance. 1.3.1.5 amounts of starting material. 1.3.1.6 batch Number. 1.3.1.7 recipient name. 1.3.1.8 expiration date (if any). 1.3.1.9 Number invoice. 1.3.1.10 placement in the warehouse. Container of starting material that was already done sampling, must be given a designation containing among others: date of the taking and implementing sampling. Sample request form the starting materials listed in Annex VII. 2. The example Records the receipt of the starting materials listed in Annex VII. 3. 1.3.2 the acceptance and delivery of the starting material Should always be recorded and checked the truth of the identity, quantity and batch number are in or out. 1.3.2.1 registration can be done manually or by using a computer program. www.djpp.depkumham.go.id 2010, no. 361 80 1.3.2.2 should always applied the principle of First In First Out (FIFO) and First Expired First Out (FEFO) for spending on ingredients. 1.3.2.3 packaging Material which is a change from the production area to do re-examination, calculated and recorded. 1.3.2.4 raw material which is already weighted can only be returned to the warehouse after the approval of the quality control Section. 1.4. Material rejected rejected Materials 1.4.1:1.4.1.1 can be caused by a variety of circumstances, for example, 1.4.1.1.1 does not meet specifications. 1.4.1.1.2 does not comply with the order. 1.4.1.1.3 is leaking, dirty or contaminated. 1.4.1.1.4 expired. 1.4.1.2 should immediately be labelled "rejected" (generally red in color) and followed the process of the Administration, namely the reduction of the stock of materials if the material was already recorded in the stock. 1.4.1.3 moved to a special area for further processing. Access to the area should be limited, when necessary snaps. 1.4.1.4 further proceedings reversion to be either suppliers or the destruction of the material. 1.4.1.5 POB to process refusals must be available and understood by the associated part. The rejection decision done by the quality control Section. Examples of POB reception, storage and delivery of the starting materials listed in Annex VII. 4. 1.5. The system of Awarding Number Batch 1.5.1 is quite clear. 1.5.2 System Batch Number batch number 1.5.2.1 the grant should be based on the POB regarding Ordinances granting batch number so it brings the same understanding for personnel/part that entails. 1.5.2.2 A batch number can provide information, for example: 1.5.2.2.1 Date, month, year and number sort of manufacture that product. 1.5.2.2.2 country of the manufacturer. 1.5.2.2.3 stages of production. 1.5.3 the placement Number Batch Number batch 1.5.3.1 be imprinted on the etiquette of the container (primary packaging) and wrap the outside of the finished product (secondary packaging) that is easy to read. If not possible, the inclusion of a minimum batch number on the label of the container of the product (primary packaging). www.djpp.depkumham.go.id


2010, no. 361 81 1.5.3.2 this batch Number be printed using a special ink so it is not easily removed, or by using the printing press (embossed). 1.5.4 Batch Number Granting Records all records must be kept of batch numbers: 1.5.4.1 for each finished product. 1.5.4.2 During a certain time period. 1.5.4.3 As factors for search again. Example Batch Number Granting POB/Lots listed on Annex VII. 5. 1.6. Weighing and measurement weighing room Area/1.6.1:1.6.1.1 Should separate, location can be in the barn or in the production. 1.6.1.2 always clean, dry and well maintained, before, during and after the activity of weighing. 1.6.1.3 dust-collecting tool Provided (dust collector), Hoover (vacuum cleaner) or other tools (a special absorbent material) to tackle pollution when the occurrence of spills or leaks of raw material. 1.6.1.4 Provided area/transit room (staging area) that are separated by area/space weighing. 1.6.1.5 all activities in the area of weighing must follow the POB. 1.6.1.6 Tool weighing: 1.6.1.6.1 Capacity, accuracy and precision tools weigh used should correspond to the amount of material which is weighed. 1.6.1.6.2 the scales used are always in good condition and clean. 1.6.1.6.3 Calibrated at regular intervals and labeled the calibration status. 1.6.1.6.4 Instructions work weighing which describes how weighing, capacity and accuracy scales are placed near the scales. 1.6.1.7 Weighing 1.6.1.7.1 raw materials can be located in space weighing is the raw material that will be weighed. 1.6.1.7.2 raw materials that will be weighed must have a clear identity and labels already be sanctioned. 1.6.1.7.3 carried out in accordance with the POB Weighing. 1.6.1.7.4 is only done by trained and competent personnel and are tasked to do the weighing. www.djpp.depkumham.go.id 2010, no. 361 82 1.6.1.7.5 Personnel weighing must use work equipment in accordance with the conditions and type of raw material. 1.6.1.7.6 for each weighing must be made proof of truth, accuracy, and the identity and amount of material that is weighted by different personnel. 1.6.1.7.7 the results of the weighing of raw material for one batch, be placed on the pallet and given a group identity tagging product name and batch number are obvious. 1.6.1.8 Container 1.6.1.8.1 Containers weighing selected be closed, adapted to the volume and nature of the materials that were weighed. 1.6.1.8.2 For materials susceptible to microbial contamination and let the used equipment and containers which are already disanitasi. 1.6.1.8.3 Avoid the use of containers between (the container to hold some materials from the drums to taken to weighing) during the preparation process of weighing to avoid contamination of the material. If not possible, between the container used must be clean and sealed and labelled the identity and status are the same as the original. 1.6.1.8.4 weighing Containers must be clean and labeled identity. 1.6.2 Notes 1.6.2.1 weighing all activity must be noted of weighing. 1.6.2.2 Results weighing must be checked by different personnel before mixing began. 1.6.2.3 When in one production batch used some of the raw material batch number, let the batch number of each note along with the amount of each ingredient used. 1.6.2.4 materials already weighed should be labeled a clear identity and complete that contain among other things: the name of the raw material/code, batch number, the net weight of the raw materials, tara, on weighing, paraf, paraf penimbang other personnel who perform checks resetting and when necessary a security symbol for harmful and toxic raw materials. 1.6.2.5 aforesaid identity Label attached to the Batch Processing Records. An example of a work Instruction (IK) Weighing of the raw materials listed in Annex VII. 6. www.djpp.depkumham.go.id 2010, no. 361 83 1.1. Procedures and processing of all materials will be 1.7.1 used certainly does have a clear label. If a label is missing or unclear, then the raw materials should be identified by the quality control before use. 1.7.2 POB Processing batch sizes are created for and certain production tools approved by the Section of production and quality control Section. 1.7.2.1 Condition processing room be monitored and controlled up to a level that is required. 1.7.2.2 Before processing begins processing room be exempt from ingredient product or document that is not required. 1.7.2.3 All equipment should be checked prior to use. The cleanliness of the equipment must be declared in writing. 1.7.2.4 Operators should understand all the stages of the activities to be implemented. 1.7.3 Surveillance during processing is done in the production area by personnel and production or quality control. All activities of supervision during processing, ranging from examination of truth and the suitability of the materials, equipment, mixing, temperature control, its homogeneity, pH, viscosity and others must be noted on the record Batch Processing or on a special form. When the results deviate from the specified limit, be conducted an investigation into the irregularities and the results are reported and recorded in the Batch Processing Records and approved by authorised personnel. Sampling can be done during the process of processing and packaging. 1.7.4 Product ruahan should be given a clear marking on product names, stages of the process, batch number, status, amount, date of manufacture that is affixed on the containers. Whenever possible, the product ruahan is kept in a special area while waiting for the release of part of the quality control for the next process. 1.7.5 to avoid the possibility of cross-contamination in the processing stages, need to do specific business eg: 1.7.5.1 processing equipment must be clean, safe, appropriate in size and is suitable for the type of product that was made. 1.7.5.2 Manufacture different products is not done simultaneously in the same room, except when there is no risk of mix-up or mix the contamination. 1.7.5.3 Avoid making different color powder product or type in an indoor production simultaneously. 1.7.5.4 access to production areas should be limited, only intended for certain personnel. www.djpp.depkumham.go.id 2010, no. 361 1.7.5.5 84 Containers that are used for processing must be in a clean state and after use should be immediately cleaned up. 1.7.5.6 processing process improvement Activities and equipment must not cause a decrease in the quality of the product. 1.7.5.7 Cleanup processing area or line of packaging should be done to avoid interfering baur starting materials or products. 1.7.6 special conditions that are necessary for the processing of a product should always be adhered to. Special conditions room must be listed in the Parent Processing Procedures and the results of his observations are recorded. 1.7.7 All processing activities should be recorded in a Note Batch Processing. Tangible results of each stage of the processing should be noted and compared with theoretical results (reconciliation). In case of irregularities should be investigated in order to be corrected or done the right precautions. During the investigation, the products were not sanctioned. Sample Batch Processing Readiness Checklist are listed on Annex VII. 7. 1.1. The dry Product Handling dry materials often creates problems of cross contamination, air contamination and health problems for personnel due to dust at the time of the processing or packaging so that require special attention. 1.8.1 air contamination, Cross-Contamination and possible problem for health personnel can be reduced by: 1.8.1.1 Use dust control systems, vacuum in the mixing room, weigh space, space filling and packaging. 1.8.1.2 effective vacuum cleaner Systems are installed with proper disposal hole layout to prevent contamination of product or other processes. Engine 1.8.1.3 mixer, sieve and filling are equipped with dust-control systems. 1.8.1.4 closed room, with separate areas of wet process. 1.8.1.5 Use spaces between (water lock). 1.8.1.6 safety protective equipment for personnel. 1.2. product wet wet vulnerable Products polluted 1.9.1 because it is a good growing medium for microorganisms. To reduce the population of microorganisms on product processing wet process then please note the cleaning process, water and sanitation equipment used. At the time of cleaning equipment, must be considered part of the slope and the hard part is achieved. www.djpp.depkumham.go.id


2010, no. 361 85 measuring stick should only be used for a particular container and has been calibrated to the containers in question. Each Reed is only used for one container only. Let this stick is made from a material that does not react and do not absorb. POB cleaning and Sanitizing of equipment should be made in order to guarantee getting the desired result. The effectiveness of the cleaning and sanitation procedures should be proven through examination of microbiology. 1.9.2 implicit production system is a system where all the processing of the raw materials mixed are covered through the removal process with pressurized air. The mixing process is in a closed tank, transfer and charging products made through a closed piping system to ensure no contaminated products. Tagging on a pipeline system should indicate the direction of flow and can guarantee that the product/material transmitted to the proper section. In a closed system be equipped with proper equipment to conduct surveillance over processing, among other faucets for sampling, measuring the speed of the stirrer. Cleaning and sanitation in a closed system is equipped with a means of Cleaning in Place (CIP). Generally used tank and piping made of stainless steel. 1.9.3 when used in piping systems for the transfer of raw materials and products ruahan, should be made a system which facilitates the cleaning and sanitation for example construction tools not much slope that can lead to stagnation or dead leg/end. Sample Checklist for processing of Creams Before Operations are listed on Annex VII. 8. 1.10. product Aerosols an aerosol Product has 1.10.1 special that can cause explosions resulting from the use of a gas suppressor (propellant) are flammable. Therefore, the required special means of especially from the side of security. 1.10.2 specific requirements for aerosol production areas, among others: 1.10.2.1 location or a separate building, with the placement of a gas safe (e.g. protected by walls that explosion, electrical systems are safe and others). 1.10.2.2 good air flow. 1.10.2.3 explosion-proof equipment and Buildings (explotion proof). 1.10.2.4 gas Detectors for flammable propellant. Sample Processing Procedure POB Parent listed on Annex VII. 9. Sample Batch Processing Records listed in Appendix VII. 10. 1.11. Labeling and packaging machinery packaging equipment/1.11.1 should always be in good condition and clean before use, characterized by the presence of clean label. Before use, a line of packaging should be cleaned from previous products and packaging materials for example label/etiquette, a container, a finished product or www.djpp.depkumham.go.id 2010, no. 361 86 other items that have nothing to do with the process of packing to do. This is to reduce cross-contamination and mix baur. Different products, not packaged in an adjacent location unless there is physical separation, for example, the distance between the line of packaging at least 1 ½ metres measured from the outer side. 1.11.2 during the process of packaging and labeling must be done random sampling for the inspection of weights and appearance as well as for quality checks include description/organoleptik, physics, chemistry and microbiology. Example taken should represent a period of packing carried out, by taking a sample at regular intervals. The number of sample taken depends greatly of the level of precision. Sampling was performed at least at the beginning, middle and end of charging and or in the event of damage/repair tools. The inspection can be performed immediately after sampling, or a specific time in accordance with the specifications. When found deviations during the process of packaging and labeling, the process of packaging and labelling can be stopped instantly. 1.11.3 at time of use, the lines should be given identity products that are packaged, such as product name, batch number and size that can be seen clearly. One line of packaging in one certain unit of time is only used for a range of products in order to avoid tercampurnya one product with another product. Products that have been incorporated into the final container is labeled but not yet be detached and given to keep are not mixed with any other product. 1.11.4 at the end packaging and labeling, let this be done counting back the (reconciliation), the final product is obtained, the remaining components of the container and lid, Roper and others. This reconciliation is recorded on the record Batch Packing. Only products that come from one batch of packaging that could be placed on one palette. When the cardboard is not full then the amount of packaging that is in the carton should be written on. The rest of the packaging material is returned to the warehouse, with a record number of details of the used or rejected. To be denied further processing in accordance with the POB. Any material that was already coded batch, but not used, logging must be done and returned to the warehouse to be destroyed. After reconciliation, such products be quarantined pending the release of part of quality control. www.djpp.depkumham.go.id 2010, no. 361 87 Examples list of Examination means of Packaging listed in Annex VII. 11. Examples of packaging listed in Attachment POB VII. 12. Examples of stem Packing Procedure POB listed on Annex VII. 13. Example Batch Packaging Records listed in Appendix VII. 14. 1.12. The finished product, quarantine, and delivery to the warehouse of finished products all labels associated with the finished product must be clearly visible. Products that already sanctioned by the quality control section of the note on the card stock of finished products. When the product does not pass the test, should be labelled as a product rejected and physically separated for actionable in accordance with POB. Sample letter delivery of the finished products listed in Annex VII. 15. Examples of POB reception, storage and delivery of the finished products listed in Annex VII. 16. Examples of card stock finished products listed in annex VII. 17. Examples of Product Handling Incompatible POB listed on Annex VII. 18. www.djpp.depkumham.go.id 2010, no. 361 88 Annex VII. 1 (example) RECOMMENDATION LABEL/TAGGING (ATTACHED on the CONTAINER or PACKAGING MATERIAL/COSMETIC PRODUCTS) of the COMPANY NAME of the STARTING MATERIAL DESIGNATION material: ... ... ... ... ... ... ... ... ... .... : …………………. BATCH NUMBER: QUARANTINE ... ... ... ... ... ... ... ... ... ... ... .... THE MAKERS/SUPPLIERS: ... ... ... ... ... ... ... ... ... ... ... .... ADMISSION NUMBER: ... ... ... ... ... ... ... ... .... FILING DATE ... ... ... ... ... ... ... ... ... ... ... ... THE NUMBER OF RECEIVED:............................ NUMBER OF CONTAINERS:.................................. SAMPLING DATE: ... ... ... ... ... ... ... .... By:......................... LABELS FOR INGREDIENTS OR PRODUCTS THAT SANCTIONED COMPANIES............................. QUALITY CONTROL PART OF SANCTIONED DATE.......................... THE NAME OF THE PRODUCT/MATERIAL: ... ... ... ... ... ... ... ... ... ... ... ... .... BATCH NUMBER: ... ... ... ... ... ... ... ... ... ... ... ... .... SUPPLIER/MAKER: ... ... ... ... ... ... ... ... ... ... ... ... .... ACCEPTANCE REPORT NUMBER: ... ... ... ... ... ... ... ... ... ... ... ... .... Amount: ... ... ... ... ... ... ... ... ... ... ... ... .... CERTIFICATE NUMBER ANALYSIS: ... ... ... ... ... ... ... ... ... ... ... ... ... RE: TEST........................... Date ... ... ... ... ... ... ... ... .... SIGNATURE: LABELS FOR INGREDIENTS OR PRODUCTS WERE REJECTED BY THE COMPANY ... ... ... ... ... ... ... ... ... ... ... ... ... ... QUALITY CONTROL SECTION REJECTED THE NAME PRODUCT/MATERIAL: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Number. BETS : ................................................. SUPPLIER/MAKER: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... ACCEPTANCE REPORT NUMBER: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... NOMOR KODE : ................................................. JUMLAH : ................................................ CERTIFICATE NUMBER ANALYSIS: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... Signature:............................................. www.djpp.depkumham.go.id 2010, no. 361 89 TAGGING to MATERIALS or PRODUCTS are BEING TESTED AGAIN the COMPANY ... ... ... ... ... ... ... ... ... ... ... ... BEING TESTED AGAIN THE PRODUCT/MATERIAL: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... BATCH NUMBER: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... SUPPLIER/MAKER: ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... ADMISSION NUMBER: ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... THE NUMBER OF RECEIVED:.................. DATE OF RECEIPT: ... ... ... .... CERTIFICATE NUMBER DATE OF ANALYSIS: ... ... ... ... ... ... ... .... : ……………. NUMBER OF CONTAINERS:......................................... FILING DATE EXAMPLE: ... ... ... ... ... By: ... ... ... ... .... LABEL PRODUCTS BETWEEN THE COMPANY PRODUCT NAME ... ... ... ... ... ... ... ... ... ... ... .... : ……………………… BATCH NUMBER: ... ... ... ... ... ... ... ... .... GROSS AMOUNTS NET OF TARA: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... NUMBER OF CONTAINERS:............................ SIGNATURE:............................. Date:..................... PRODUCT LABEL RUAHAN COMPANY PRODUCT NAME ... ... ... ... ... ... ... ... ... ... ... .... : ……………………… BATCH NUMBER: ... ... ... ... ... ... ... ... .... GROSS AMOUNTS NET OF TARA: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... NUMBER OF CONTAINERS:............................ SIGNATURE:............................. Date:..................... www.djpp.depkumham.go.id


2010, no. 361 90 Annex VII. 2 (example) STARTING MATERIALS REQUEST FORM REQUEST FORM the STARTING MATERIAL raw material packaging Material number: ... ... ... ... ... .... Date:................... Product code ... ... ... ... ... .... The product ... ... ... ... ... .... Batch Number ... ... ... ... The Size Of The Batch ... ... ... ... Shape Of Hardware ... ... ... ... The Size Of The Package............ Delivery Date ... ... ... ... The name of the material Code Number Nominal amount of certificate of analysis the unit of the number of Real Paraf 1. ... 2. ... 3. ... 4. ... 5. ... 6. ... 7. ... 8. ... 9. ... 10 ... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... Checked by approved by request from: head of warehouse:.................... Date: Paraf: date: Paraf: date: Paraf: www.djpp.depkumham.go.id 2010, no. 361 91 Annex VII. 3 (example) NOTE RECEIPT of STARTING MATERIAL RECEIPT of STARTING MATERIAL raw material Packaging Material number: ... ... ... ... ... ... ... ... ... ... .... Name Of Material: ... ... ... ... ... ... ... ... ... ... .... Number Date name of Supplier Invoice Number Batch Number number of Units approved by head of warehouse Paraf..................... Date: ... ... ... ... ... Paraf: ... ... ... ... ... www.djpp.depkumham.go.id 2010, no. 361 92 Annex VII. 4 OPERATIONAL PROCEDURES (example) BAKU RECEPTION, storage and DELIVERY of INITIAL MATERIAL page 1 of 1 RAW OPERATIONAL PROCEDURES RECEPTION, storage and DELIVERY of INITIAL MATERIAL number ... ... ... ... ... ... .... THE COMPANY'S NAME............................ PART.............................. Sexy........................... Date ... ... ... ... Compiled by ... ... ... ... ... ... ... ... ... .... Tanggal ............................. Review by........................... Tanggal ................................... Approved by........................... Tanggal ................................... Replace The Number ... ... ... ... ... ... ... ... ... ... .... Tanggal ............................... 1. The PURPOSE of these procedures created for the implementation and supervision of reception, storage and delivery of the starting materials. 2. the PERSON in CHARGE of the head of the warehouse is responsible for the implementation and supervision of reception, storage and delivery of the starting materials. 3. PROCEDURES 3.1 Examine the integrity of the packaging, label and number of truth the starting materials are received by letter the way and mail order. 3.2 Create starting material receipt with a copy delivered to the quality control, purchasing, Accounting and production Planners. 3.3 Give quarantine label on each pack or the bottom of each pallet packaging and stored in a quarantine area. 3.4 Note goods received in the card stock. 3.5 quality control Officer will take the sample in accordance with POB Sampling starting materials. 2.2 starting materials that are sanctioned by the quality control and has been labeled a "Sanctioned" should be immediately transferred to the storage of the starting material tested. Note the status of the starting materials (passed or rejected) in the card stock. 2.3 starting materials that are rejected by the quality control Section is labelled "rejected" and stored in the storage area of the rejected material. 2.4 Only the starting material has been tested and has not been beyond the expiration date just to be turned over to the production. 2.4 Any surrender of the starting materials must follow the principles of FIFO (first in first out) and FEFO (first expired first out); must comply with the letter of request from the starting materials production; and must be recorded in the card supplies starting materials. 3.10 as soon as finished weighing the starting materials, containers must be closed tightly. 3.11 should notify the head of warehouse Parts quality control in terms of the starting materials are almost expired or close to the date of the test. This notification was carried out 3 (three) months before the expiration starting materials. 3.12 Any starting material the spill should not be returned to the original in a container but must be destroyed and reported to the hierarchical Leadership. 3.13 Any inventory differences between starting material reality and bookkeeping should be carefully examined and reported to the hierarchical Leadership as well as the letter of the initial inventory adjustments were made and the letter must be approved by the leadership before it is given to the Bookkeeping (Accounting). www.djpp.depkumham.go.id 2010, no. 361 93 Annex VII. 5 (example) OPERATING PROCEDURES of RAW BATCH/LOT NUMBER GRANTING page 1 of 1 the OPERATIONAL PROCEDURE of RAW BATCH/LOT NUMBER GRANTING company name............................ PART.............................. Sexy........................... Number ... ... ... ... ... ... Effective date............................. Compiled by ... ... ... ... ... ... ... ... .... Tanggal .................................... Review by............................... Tanggal ....................................... Approved by............................. Tanggal ..................................... Replace The Number ... ... ... ... ... ... ... ... ... ... Tanggal ..................................... 1. product Ruahan examples for batch Number lot Number: 4 15 042:4 15 042 A 1.1 the first Digit indicates the year of production which is coded as follows: for the year 2004:4, 2005:5 and so on. 1.2 the second and third Digits show the product code of the product ruahan. 1.3 Fourth Digit, the fifth and sixth production shows the sequence 001, 002, s/d 999 in the same year. 1.4 the seventh Digit indicates the order of the lot from a batch of 2. Example: A finished product 4 15 042 1 2.1 the first Digit indicates the year of packaging. 2.2 second Digit until seven shows the number of the batch of products ruahan. 2.3 the eighth Digit shows the sequence of lots of product batch ruahan. www.djpp.depkumham.go.id 2010, no. 361 94 Annex VII. 6 (example) RAW MATERIAL WEIGHING INSTRUCTIONS page 1 of 1 INSTRUCTIONS WEIGHING RAW MATERIALS company name............................ PART.............................. Sexy........................... Number ... ... ... ... ... ... Effective date............................. Compiled by ... ... ... ... ... ... ... ... .... Tanggal .................................... Review by............................... Tanggal ....................................... Approved by............................. Tanggal ..................................... Replace The Number ... ... ... ... ... ... ... ... ... ... Tanggal ..................................... 1. check the function of the appliance the scales at least once a day at a time will start with weighing: 1.1 examination of the zero point: the needle or pointer should point to zero the scale. 1.2 place the children of the scales of different sizes and read. 2. check the cleanliness of the room, weighing weigh, container for weighing. 3. check spaces weighing; the room should be free of other materials except materials which will be weighed for the batch. 4. Clean the outside of the container-the container of raw materials before moving it into the space weighing. 5. use scales that correspond to the amount of material that will be weighed. The smallest amount that can be weighted depending on the capacity and sensitivity of the scales. As a minimum amount that can be weighed is 20 x the smallest reading numbers stamped on the appliance the scales and the maximum amount that can be weighed is 95% of the maximum capacity of the tool of the scales. 6. Wear adequate clothing, head coverings, gloves and masks. www.djpp.depkumham.go.id 2010, no. 361 95 Annex VII. 7 (example) LIST of BATCH PROCESSING READINESS INSPECTION company name..................... BATCH PROCESSING READINESS CHECKLIST The Product ... ... ... ... ... ... ... ... ... ... ... Batch Number. ........................... Big Batch ... ... ... ... ... ... ... ... .... Tanggal .................................. Day 1 Morning Inspection object. Wall/ceiling/non of the spider's nest/fungi 2. Clean floor 3. Machinery/tank attached "clean" label 4. Label attached process identity (name, Batch Number, stage of the process) 5. Wash hands clean and soapy/tissue available 6. Raw ingredients 1 batch collected, not mixed material/ruahan/another batch of 7. Drums/containers-container ruahan label attached and 8. The scales are already set/calibration 9. Product ruahan/half so there is already a label "SANCTIONED" 10. Humidity and room temperature. Batch Processing records filled in accordance with the stage that is being worked on. Personnel wear masks and gloves take note of date ... ... ... ... ... ... ... ... ... ... .... The examiner ... ... ... ... ... ... .... www.djpp.depkumham.go.id 2010, no. 361 96 Annex VII. 8 (example) CHECKLIST for PROCESSING the CREAM BEFORE the OPERATIONAL company name................................... CHECKLIST For PROCESSING OPERATIONAL BEFORE CREAM Products: ... ... ... ... ... ... ... ... ... ... ... ... ... Batch Size:............................... Batch Number: ... ... ... ... ... ... ... ... ... The date of the Examination Object checked by 1. Batch processing of entry 2. Clean Processing space 3. Only raw materials for the batch in question are in the processing space 4. Personnel wear the head coverings, gloves and a protective mask face processing: 1. Vessel Melting a. labeled "net" b. Net 5. c. clean containers and tools 2. A. stirrer tool is labeled "net" b. Cleaner c. assistive Equipment and containers clean www.djpp.depkumham.go.id


2010, no. 361 97 Annex VII. 9 (example) OPERATIONAL PROCEDURES of STEM PROCESSING PROCEDURE RAW page 1 of 2 RAW PROCESSING PROCEDURE OPERATING PROCEDURE of the PARENT COMPANY'S NAME...................................... PART.............................. Sexy........................... Number ... ... ... ... ... .... Effective date............................. Compiled by ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... .... Review by............................. Date ... ... ... ... ... ... ... ... ... .... Approved by.................................. Date ... ... ... ... ... ... ... ... ... Replace The Number ... ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... .... Product code Product Name 1234 Eye Shadow 415042 Large Batch Number Batch 100 Kg of solid Dosage Form Powder 10 g Pot Packaging Date processing Begun:...................... Finish: ... ... ... ... ... ... ... ... .... 1. The COMPOSITION of the phases of A 4% Triglyceride Cyclo Dimethicone Polyglyceryl-3 Oleate% 0.75% Vitamin E Acetate 1% Phase B Pearl White Mica Mica Spheres 31% 20% 20% Talc Powder Beige Mica 5% Magnesium Stearate 5% Bismuth Oxychloride 5% Titanium Dioxide 5% 2. SPECIFICATION 3. EQUIPMENT 4. WEIGHING the amount of ingredients needed for batch 1 = 100 Kg of material Code Name ingredients amount required (g) the amount weighed (g) Batch Number weighted by checked by Phase A Triglyceride Cyclo-Dimethicone Polyglyceryl Oleate Vitamin E Acetate Phase B Pearl White Mica Mica Powder Talc Spheres Beige Mica Magnesium Stearate Bismuth Oxychloride Titanium Dioxide 4000 3000 750 1000 31000 20000 20000 5000 5000 5000 5000 ... ... ... ... .... ABC Amir Badu www.djpp.depkumham.go.id 2010, no. 361 98 page 2 of 2 RAW PROCESSING PROCEDURE OPERATING PROCEDURE of the PARENT COMPANY'S NAME...................................... PART.............................. Sexy........................... Number ... ... ... ... ... .... Effective date............................. Compiled by ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... .... Review by............................. Date ... ... ... ... ... ... ... ... ... .... Approved by.................................. Date ... ... ... ... ... ... ... ... ... Replace The Number ... ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... .... 1. PROCESSING PROCEDURE processing Stage Paraf Operator Supervisor 1. Mix the Titanium dioxide and Mica Pearl White in a mixer until homogeneous (Phase B) 2. Add the other ingredients: Mica Spheres, Talc Powder, Beige Mica, Magnesium Stearate, Bismuth Oxychloride mix until homogenous 3. Mix the Triglyceride, Dimethicone, Polyglyceryl Cyclo-Oleate, Vitamin E Acetate in a saucepan stir until homogeneous (Phase A) 4. Mix the phases A to mix No. 2 then stir until homogenous 5. Sift the powder mixture already homogeneous using the sieve mesh 100 6. Enter into molds 2. RECONCILIATION Reconciliation results checked by approved by the theoretical Results: ... ... ... ... ... ... .... Real results: ... ... ... ... ... ... .... Limit results:............% if tangible results beyond those results above, do "an investigation into the failure of the" Supervisor of processing dates ... ... ... ... ... .... Head Of Production Date................ Processing Supervisor Processing Inspection Date: ... ... ... ... ... ... ... .... Head Of Production Date: ... ... ... ... ... The review Notes the processing of Batch quality control Section Head date:.............................. www.djpp.depkumham.go.id 2010, no. 361 99 Annex VII. 10 (example) BATCH PROCESSING RECORD company name................................. NOTE the BATCH PROCESSING Code of the product ... ... ... ... ... The name of the product ... ... ... ... ... Batch Number ... ... ... ... ... Big batch ... ... ... ... ... .... Shape of hardware ... ... ... .... Packaging ... ... ... ... ... Date processing Begun: ... ... ... ... ... ... Finish: ... ... ... ... .... 1. The COMPOSITION of the Base Unit 1.1, e.g. active substances 0.07 g/100 mL. 2.1 the amount of ingredients needed for 1 batch. 2. SPECIFICATIONS 3. EQUIPMENT 4. Material Code Name WEIGHING ingredients amount required (g) the amount weighed (g) Batch Number weighted by reviewed by 5. PROCESSING PROCEDURE processing Stage Paraf 6. RECONCILIATION Reconciliation results checked by approved by the theoretical Results: ... ... ... ... ... ... .... Real results: ... ... ... ... ... ... .... Limit results:............% if tangible results beyond those results above, do "an investigation into the failure of the" Supervisor of processing dates ... ... ... ... ... ... .... Head Of Production Date................ Processing Supervisor Processing Inspection Date: ... ... ... ... ... ... ... .... Head Of Production Date: ... ... ... ... ... ... ... ... The review Notes the processing of Batch quality control Section Head date:.............................. www.djpp.depkumham.go.id 2010, no. 361 100 Annex VII. 11 (example) LIST of EXAMINATION MEANS of PACKAGING company name....................... LIST Of INSPECTION MEANS For PACKAGING Material Name ... ... ... ... ... ... ... ... ... Batch Number ... ... ... ... ... ... ... ... ... .... Packaged For.......................... Tanggal ..................................... Quality Control Section Head ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Review By........................ No. Object Inspection DESCRIPTION 1. Permission of packaging has been around 2. A clean work space 3. Only items which are required for the batch that will be packaged that have been sanctioned at the workplace 4. Sub-materials which will be packed with sufficient number of packaging materials are separated far enough 5. The machines used a. labeled "clean" clean condition b. c. Operator machine wear gloves and masks d. Permit road machines have been around e. during the process of Examination is conducted properly 6. The materials used have been sanctioned and appropriate examples are shown in place of the packaging. The name; Batch Number; The Expiration Date. a. b. Roll the Strip c. Plastic bottle/glass bottle Label d. e. Dos f. Brochure g. Label outside of h. i. Plastic outer Dos 7. The amount that is packed in accordance with packing specifications a. Per Unit b. Per dus c. Per cartons out d. Per box note................................................ Date ... ... ... ... ... ... ... .... Checked by quality control Section Head.......................... www.djpp.depkumham.go.id


2010, no. 361 101 Annex VII. 12 (example) OPERATIONAL PROCEDURES of PACKAGING RAW page 1 of 1 RAW OPERATIONAL PROCEDURE P E N G E M A S A N company name.............................. PART........................... Sexy........................... Number ... ... ... ... ... ... ... .... Effective date................................ Compiled by ... ... ... ... ... ... ... ... ... ... Date ... ... ... ... ... ... ... .... Review by............................ Date ... ... ... ... ... Approved by................................ Date ... ... ... ... ... ... ... ... .... Replace the number ... ... ... ... ... ... ... ... Date ... ... ... ... 1. The PURPOSE of this procedure is made to the guidelines for personnel in performing packaging the finished product. 2. the PERSON in CHARGE is responsible for packaging the finished product is a packaging supervisor. 3. PROCEDURE 3.1. Personnel entering the packing room should wear clean specifically for work, work shoes and wear a head covering and if need to wear masks and gloves. Personnel prior to packaging should wash her hands before using SOAP and if necessary continue with disinfection liquid. 3.2. Before packing process begins, the supervisor portion of packaging should check the cleanliness of the room and the tools that will be used for packing process and there is no material or product other than that will be packed. 3.3. any packaging materials from warehouse receipt be reviewed carefully regarding truth and amount. 3.4. Make a note of the amount of packaging that is received, used, destroyed and returned to the warehouse. 3.5. packaging Material which have been given the designation be stored in containers tightly closed and sealed and labelled are clear. 3.6. All containers will be used to store packaging material or finished product be checked for cleanliness and there is no other labels. 2.3. Packing process should only be implemented once approved by a supervisory officer. 2.4. On every line of packaging should be given a clear sign that shows what products are packaged and numbered betsnya. 2.4. all containers of finished products that have been packaged should be labelled are clear. 3.10. to sanitize the tools, use a vacuum cleaner tool then continue cleanup in a manner that has been established. 3.11. In space packing prohibited eating, drinking, chewing and smoking. 3.12. during the packing process in a certain time interval should review the suitability of the finished products are packed with predetermined specifications. Record the inspection results in the inspection records during the process (In-Process Control) 3.13. Packing supervisor should keep an eye on the calculation and the destruction of material packaging and product ruahan can not be returned to the warehouse. 3.14. The supervisor should calculate the amount of packaging the finished product that is delivered to the warehouse. Note the number of finished product sent to a warehouse in the delivery of the finished product. Any irregularities occurred the result that exceeds the established irregularities, supervisors re-examine yourselves as well as packing shed written why it can happen. 3.15. The supervisor should match the packaging material packaging and packing at the end of ruahan products. 3.16. packaging Line as well as the tools used for packaging should be cleaned as soon as the packing process ends, then given a label that lists the names of the clearing, the date the products are cleaned and packaged. 3.17. results of this packing finished products should be labelled in a clear and declared a quarantine status until sanctioned by quality control Section. www.djpp.depkumham.go.id 2010, no. 370 102 Annex VII. 13 (example) OPERATIONAL PROCEDURES for the RAW STEM PACKING PROCEDURES page 1 of 1 RAW PACKAGING PROCEDURES OPERATING PROCEDURES of the PARENT COMPANY'S NAME................................... PART........................... Sexy........................... Number ... ... ... ... ... ... ... ... ... .... Effective date............. Compiled by ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... .... Review by............................ Date ... ... ... ... ... ... .... Approved by............................ Date ... ... ... ... ... ... .... Replace The Number ... ... ... ... ... ... ... ... ... ... ... ... .... Date ... ... ... ... ... ... ... ... Product Code ... ... .... The Name Of The Product ... ... .... Batch Number ... ... .... Big Batch ... ... .... Shape of hardware ... ... .... Packaging ... ... .... Packing date started: ... ... ... ... ... ... Finish: ... ... ... ... .... 1. acceptance and reconciliation of materials packaging material Code Paraf Amount Amount Name packaging materials Required kan received number of QC in the decline in use in the restore Warehouse Production date of return packaging materials: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Packing Supervisor: Paraf.................................................. Note: checked by: Date: Section Head ... ... ... ... ... ... ... ... ... ... .... Approved by the quality control Section Head: date:.......................... 2. the charging Procedure the charging Procedure Paraf 3. The tagging procedure and packaging labelling and packaging Procedures Paraf 4. Release by Release final quality control of finished product number ... ... ... ... ... ... ... ... date ... ... ... ... ... .... Catatan:.......................................................................................................................................... Inspection Of The Packing Process Supervisor Packing Date: ... ... ... ... ... ... ... .... Head Of Production Date: ... ... ... ... ... ... ... ... ... ... ... The review Notes the packaging Batch quality control Section Head date:.............................. www.djpp.depkumham.go.id 2010, no. 361 103 Annex VII. 14 (example) PACKAGING BATCH RECORDS company name................................... Product code BATCH PACKAGING RECORD ... ... ... The name of the product ... ... ... Batch Number ... ... ... Big batch ... ... ... Shape of hardware ... ... ... Packaging ... ... ... Packing date started: ... ... ... ... ... ... Finish: ... ... ... ... .... 1. acceptance and RECONCILIATION of MATERIALS PACKAGING material Code Paraf Amount Amount name of packaging material is received No Dibutukan. QC Rejected Used Returnable date Production Warehouse Return packaging materials: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Packing Supervisor: Paraf.................................................. Note: checked by: Date: Section Head ... ... ... ... ... ... ... ... ... ... .... Approved by the quality control Section Head: date:.......................... 2. The CHARGING PROCEDURE the charging Procedure Paraf 3. The TAGGING PROCEDURE and PACKAGING penandaandan packaging Paraf Procedure 4. RELEASE by Release final QUALITY CONTROL of cosmetics so number ... ... ... ... ... ... ... ... date ... ... ... ... ... .... Catatan:.............................................................................................................................................................. Inspection Of The Packing Process Supervisor Packing Date: ... ... ... ... ... ... ... ... Head Of Production Date: ... ... ... ... ... The review Notes the packaging Batch quality control Section Head date:.............................. www.djpp.depkumham.go.id 2010, no. 361 104 Annex VII. 15 (example) MAIL DELIVERY of the FINISHED PRODUCT the COMPANY: ... ... ... ... ... ... ... ... ... ... ... ... ... ... PRODUCTION SECTION: ... ... ... ... ... ... ... ... ... ... ... ... ... ... LETTER OF SUBMISSION: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... KEPADA : .................................... PRODUCT Name Batch Number/Code Number Lot number of Units Delivered by date received by Date www.djpp.depkumham.go.id


2010, no. 361 105 Annex VII. 16 (example) of RAW OPERATING PROCEDURES reception, STORAGE and DELIVERY of FINISHED PRODUCTS page 1 of 1 RAW OPERATIONAL PROCEDURES RECEPTION, storage and DELIVERY of FINISHED PRODUCTS company name................................... PART........................... Sexy........................... Number ... ... ... ... ... ... Effective date ... ... ... ... .... Compiled by ... ... ... ... ... ... ... ... ... Tanggal ................................... Review by............................... Tanggal ....................................... Approved by............................. Tanggal ...................................... Replace The Number ... ... ... ... ... ... ... ... ... ... ... ... .... Tanggal ...................................... 1. The PURPOSE of this procedure is created for the supervision of the finished product, either in quarantine status or who have been sanctioned by the quality control. 2. the PERSON in CHARGE is responsible for the receipt, storage, distribution and product stewardship so is the head of the warehouse. 3. PROCEDURE 3.1 the finished product received from the packaging parts must be checked carefully and is labeled quarantine. 3.2 submission of finished products in quarantine status must be accompanied by a letter of capitulation of the finished product. 3.3 Product has to be put in quarantine at the quarantine area and recorded in the card supplies finished products. 3.4 the finished product in quarantine status should not be distributed prior sanctioned by quality control Section. 3.5 a finished product that has been sanctioned by the quality control should be placed in the area of the finished product have been sanctioned as well as recorded in the card supplies a finished product that has been sanctioned. 3.6 Any shipping finished products must be accompanied by and in accordance with the delivery of a letter issued by the Logistics Section. 3.7 Any delivery of the finished product must be noted on the card supplies a good number of batch number and the receiver. 2.4 Any shipping finished products must follow a system of FIFO (First In First Out) means the products first entered the first issued or FEFO (First Expired First Out) means a product before the expiration of the first issued. Any deviation from this system must be with the consent of the head of the factory. www.djpp.depkumham.go.id 2010, no. 361 106 Annex VII. 17 (example) CARD STOCK PRODUCTS SO the COMPANY NAME......................................... THE CARDS FINISHED PRODUCT CODE NUMBER ... ... ... ... ... ... ... ... ... ... ... ... .... NAMA PRODUK ...................................... UNIT .......................................................... ENTER the BATCH NUMBER DATE OUT JML (Pot) DATE BATCH NUMBER DISTRIBUTOR JML (Pot) remaining Paraf/description 17/3 10ABD 1000 1000 1000 2000 11bgf 18/3 6/3 10ABD PT. 1000 1000 AWUT www.djpp.depkumham.go.id 2010, no. 361 107 18 VII. Attachments (example) OPERATING PROCEDURES HANDLING RAW PRODUCTS DO NOT FIT page 1 of 2 OPERATIONAL PROCEDURES of HANDLING RAW PRODUCT DOES NOT MATCH the NAME of the company................................... PART........................... Sexy........................... Number ... ... ... ... ... ... Effective date ... ... ... ... .... Compiled by ... ... ... ... ... ... ... ... ... Tanggal ................................... Review by............................... Tanggal ....................................... Approved by............................. Tanggal ...................................... Replace The Number ... ... ... ... ... ... ... ... ... ... ... ... .... Tanggal ...................................... 1. The PURPOSE of Providing instructions as to the action taken if there is a discrepancy between the quality of product from either chemical or physical aspects of microbiology. 2. The SCOPE of this Act apply to: basic materials stocks/base and ruahan products, finished products. 3. PROCEDURE 3.1. Ruahan products and products between (the basic ingredient Preparations/Base) 3.1.1. Ruahan products and products between (the basic ingredient Preparations/Base) were rejected due to mismatch of Chemical Physics aspect, after repairs in accordance with the limits of the allowed actions can be carried out as follows: a. After the results of the analysis and the identification of the known causes of discrepancies, then the process can be done re (re-process) after obtaining a permit from the direction of the factory. The finished product is reprocessed should be analyzed. b. Destroyed in accordance with the existing internal procedures at the plant. In the case of a discrepancy of ruahan products for Microbiology, quality control Section in charge to seek and find the cause of the discrepancy. When it is still possible to do these ruahan products decontamination can be further processed. If not possible the products decontamination must be destroyed and this action is informed to the leadership of the plant. 3.1.2. The discrepancy ruahan quality of the product and the product between (the basic ingredient preparations/base) after passing the date of validity of the pass ujinya. When a batch of a product or products between ruahan (basic materials stocks/base) was rejected due to lack of chemical physics or microbiology rendering after the period of validity of the pass ujinya, the batch of products were destroyed in accordance with the existing internal procedures at the plant. 3.2. Products that are already filled and packed 3.2.1. When discrepancies of quality is observed at the time of connection to the line of charging, then the activities of charging is stopped immediately. Analysis of the cause, for example an error connecting, problems during storage, problems due to errors in laundering equipment transfer and others, should be done by the related section. Products that are already filled and packed before solving the problem which must be destroyed in accordance with internal procedures that apply. www.djpp.depkumham.go.id 2010, no. 361 108 page 2 of 2 the OPERATIONAL PROCEDURES of HANDLING RAW PRODUCT DOES NOT MATCH the NAME of the company................................... PART........................... Sexy........................... Number ... ... ... ... ... ... Effective date ... ... ... ... .... Compiled by ... ... ... ... ... ... ... ... ... Tanggal ................................... Review by............................... Tanggal ....................................... Approved by............................. Tanggal ...................................... Replace The Number ... ... ... ... ... ... ... ... ... ... ... ... .... Tanggal ...................................... 3.2.2. The discrepancy of quality products that are already filled and packed. The rejection of the whole or part of the batch of products that already contained or packaged is based on aspects of physics, chemistry and microbiology will cause destruction of part or all of the batch. This is the basis for further investigation by the quality control. When possible, corrective actions can be carried out in particular in the process of filling and packaging directly influential on quality, e.g. violence/fragility of dense/compact product, melting lipstick and others. 3.2.3. decontamination Treatment against products which are already filled or packed. After receiving approval from the leadership of the plant, can be done from the decontamination process of the contaminated batch. This decontamination process should not affect the physical properties of chemical products or packaging materials against ruahan. All products which have undergone a process of decontamination must be retested in chemical physics or microbiology before such products can be distributed to the market. Parameters to analyze the product test should be performed decontamination introduction by quality control Section. Quality control section must inform the relevant parties will test results re treatment of finished product. An act of correction should be done every test result discrepancies occur microbiology. 3.2.4. test result Discrepancies microbiology case packaging materials against mismatch test results of microbiology from the packaging, the correction action can be done until the supplier can meet the requirements of Microbiology which has been established by the manufacturer. Quality control section provides suggestions towards corrective actions to improve the cleanliness of packaging materials against aspects of microbiology. www.djpp.depkumham.go.id


2010, no. 361 109 VIII. QUALITY CONTROL 1. Introduction quality control is the inspection and testing of all efforts that are conducted before, during and after manufacture to ensure cosmetic cosmetics produced always meets the requirements that have been set. When testing facilities are not available, the test can be done by designating an accredited laboratory. To ensure freedom in setting his decision, then part of the quality control is a part separate from the production section. 1.1 quality control System quality control Systems should include the following: 1.1.1 the system and procedure of sampling, testing, examination of the starting materials, products, ruahan products, between the finished product and a product change and environmental conditions in order to release/refusal/monitoring to meet the requirements that have been set. 1.1.2 laboratory Buildings be designed to wake up in accordance with the allocation as follows: 1.1.2.1 spatial Size of laboratory and Laboratory testing be designed, equipped and has adequate room so that it can accommodate all the necessary activities with adequate work comfort. 1.1.2.2 Provided a suitable and safe for garbage and the rest of the material will be disposed of in containers tightly closed and given a clear sign that declares the type and risk classification of waste. Toxic and flammable materials stored in a specially designed place and separate. 1.1.2.3 laboratory Spaces are not in the production of space, but it can be close to the production room, free of impurities and vibration that can affect the test results. 1.1.2.4 Space laboratory physical chemistry, microbiology and instruments are separated from each other to prevent the occurrence of contamination. 1.1.2.5 Design laboratories should heed: 1.1.2.5.1 building materials used. 1.1.2.5.2 gas Distribution as well as dangerous fumes to the outside (hood). 1.1.2.5.3 ventilation. 1.1.2.5.4 air handler Unit which is separate to the laboratory of microbiology. 1.1.2.6 Be provided: 1.1.2.6.1 place of weighing materials testing. 1.1.2.6.2 storage of solvents and reagents. 1.1.2.6.3 pertinggal examples of Storage Area. 1.1.2.6.4 standard storage of the starting material and the comparison of the finished product. www.djpp.depkumham.go.id 2010, no. 361 110 examples of Layout quality control Laboratories listed in Annex VIII. 1. 1.1.3 Personnel Each personnel should wear protective clothing and safety tools comply with the task and its activities, among others, protective glasses, masks, and gloves. For Operational Procedures need to be made that Baku (POB)-use of Safety Equipment. Examples of the usage and maintenance of POB Tools Pembasuh Eyes are listed on Annex VIII. 2. An example of a work Instruction (IK) method of mounting the Respirator for Organic Vapors/Acid listed in Appendix VIII. 3. 1.1.4 Equipment 1.1.4.1 equipment and instruments laboratory testing in accordance with the test procedure and let the starting materials and products. 1.1.4.2 Available IK operation of each instrument and equipment placed close to the instrument or apparatus in question. 1.1.4.3 Equipment and instruments be maintained and calibrated on a regular basis and its implementation is documented. Calibration labels be printed on each instrument. 1.1.4.4 equipment that is not functioning properly or are being treated is given a clear designation and should not be used before it is repaired. Examples of POB Calibration pH meter are listed on Annex VIII. 4. Examples of the use of IK pH meter are listed on Annex VIII. 5. Examples of Equipment Status Label Recommendations listed in Annex VIII. 6. 1.1.5 Reactant 1.1.5.1 Breeding and Media acceptance, creation of reactant, breeding and the way media measurement should be made and the results of its implementation POB noted. 1.1.5.2 Reactant that is made in the laboratory should be labeled accordingly include: concentration, standardization factors, usage time limit, the date of the standardization, creation date and signature of the officer who made it. The example Records the making of solution of Reactant, and the Media is listed on the Breeding Appendix VIII. 7. Example Reactant Solution Container Label Recommendations and Media Hybrids and Label the container Solution Titer is listed on Annex VIII. 8. 1.1.6 specification and test procedure test procedure let 1.1.6.1 refers to kompendia (for raw materials), otherwise the procedure should allow guaranteed its validity having regard to existing equipment facilities, which must be approved, signed, and dated by the head of the quality control Section. www.djpp.depkumham.go.id 2010, no. 361 111 1.1.6.2 Specification is a list of test parameters, refer to testing procedures, and appropriate acceptance criteria numerical limits, in the form of ranges or other criteria for the test in question, which must be approved, signed, and dated by the head of the quality control Section. 1.1.6.3 Any starting materials, products and ruahan products, between products so let have a specification and testing procedure is detailed and written. 1.1.6.4 Specifications should include, among others: 1.1.6.4.1 the name of the starting material/product. 1.1.6.4.2 Number starting materials/products. 1.1.6.4.3 description of the container and the packaging. 1.1.6.4.4 qualitative and quantitative Requirements with the acceptance limits. 1.1.6.4.5 Guide to sampling and testing or reference from the approved test procedure. 1.1.6.4.6 re-test Limits/expiration (if any). 1.1.6.4.7 Way of storage. 1.1.6.5 any deviation from predetermined Test Procedures must be reported to and approved by the head of the quality control before it is implemented. 1.1.6.6 test results, especially regarding the calculation, be reviewed by the supervisor, before reported to the head of the quality control. Sample Specifications raw material and Packaging Material listed in Appendix VIII. 9. 1.1.7 the evaluation procedures of production by quality control Section. 1.1.7.1 Part quality control should participate in making the parent Processing Procedures (listed in annex VII. 9) and Stem Packing Procedures (listed in annex VII. 13) of a product to ensure uniformity from batch to batch. Each of the changes and adjustments to the procedure for Processing the parent or the parent of packaging Procedures must be approved by the person in charge of the production Section and the section in charge of quality control before being used by a part of production. 1.1.7.2 Part quality control should give approval of POB cleaning and Sanitizing buildings (listed in Appendix VI. 9) and Sanitation and cleaning of Equipment POB production (listed in Appendix VI. 13.) 1.1.8 Notes analysis and reports the test results Be made 1.1.8.1 records analysis and reports the results of testing against the starting materials and products in accordance with the approved testing methods. 1.1.8.2 Records analysis and reports the results of laboratory testing are official documents that must be stored and maintained properly so that it can be quickly and easily found again when needed. 1.1.8.3 Record analysis should include, among others: 1.1.8.3.1 the name and batch number of examples. www.djpp.depkumham.go.id 2010, no. 361 112 1.1.8.3.2 the name of the officer who took the sample. 1.1.8.3.3 methods of analysis are used. 1.1.8.3.4 all data analysis such as weights, the reading of burette, volume and dilution. 1.1.8.3.5 calculations in unit size and the formula used. 1.1.8.3.6 Statement does meet or do not meet the requirements of the specifications. 1.1.8.3.7 the date and signature of the officer who conducts the test and officers who checked the calculations. 1.1.8.3.8 Statements are passed or rejected as well as advice on action that is signed and dated by an authorized officer. 1.1.8.3.9 the name of the supplier, the amount of starting material is received and the number of products produced. 1.1.8.3.10 the number of examples taken from any starting materials and products are analyzed. 1.1.8.3.11 number of the batch or lot number from the starting materials/products to be analyzed. 1.1.8.4 Note analysis of each of the testing that has been done should be made in the form of sheets or in the book are numbered in order of their pages to make sure that there is no analysis of the records or part of the page is missing. 1.1.8.5 certificate of analysis is a report of the test results that meet the specifications and should contain the following: 1.1.8.5.1 the name and address of the manufacturer or the Agency which issued the certificate. certificate Number 1.1.8.5.2. 1.1.8.5.3 the name of the ingredient or product and dosage forms. 1.1.8.5.4 Number of batch materials or products. 1.1.8.5.5 the test results and the value of the standard limit. 1.1.8.5.6 the date and the signature part of quality control. Sample certificate of analysis are listed on Annex VIII. 10. 1.1.9 assessment of Supplier quality control Part let 1.1.9.1 responsible along with the associated section to select suppliers that are capable and trustworthy in the provision of the starting materials that meet predefined specifications, on time and right amount. 1.1.9.2 assessment of all potential suppliers should be done before the given orders/order. 1.1.9.3 Assessment be carried out jointly by representatives from the quality control, Production and Purchasing Section to define the qualified suppliers. 1.1.9.4 assessment of all suppliers should be done periodically. Examples of Evaluation and assessment of suppliers of POB are listed on Annex VIII. 11 www.djpp.depkumham.go.id


2010, no. 361 113 1.2 quality control includes: 1.2.1 sampling, inspection and testing. 1.2.1.1 sampling. Sampling is important because only a small portion of one batch taken for testing quality. Overall conclusion regarding validity of product quality based on testing done against instances that represent a single batch. Therefore the amount of sampling should be based on statistical methods. 1.2.1.1.1 sampling Officers be trained about the proper sampling at the beginning of his Commission, and further evaluated his ability on a periodic basis. 1.2.1.1.2 sampling be carried out according POB which includes: 1.2.1.1.2.1 methods of sampling. 1.2.1.1.2.2 the number of examples that are taken. The weight or volume of a sample product raw material taken be enough for a minimum of two times complete testing specifications. The number of products so formulated that fetched as an example should suffice to final testing necessary for passing the test, plus the amount saved for example pertinggal included for stability testing if necessary. 1.2.1.1.2.3 tool used in sampling be clean. When taking a sample from a different batch be used tools that are new or that have been previously cleaned. 1.2.1.1.2.4 type and the condition of the used sample containers be made of glass, plastic or stainless steel that will not affect the quality of the materials or products at the time of direct contact. 1.2.1.1.2.5 Identification of the sample container. 1.2.1.1.2.6 instructions for closing the back of the container immediately after sampling and given the designation stating that a sample had been taken from the container in question. 1.2.1.1.2.7 special measures for sampling hazardous materials. 1.2.1.1.2.8 Instructions for cleaning and storing tools sampling. 1.2.1.1.3 identity testing To be conducted sampling of raw materials of every container received. 1.2.1.1.4 for testing the full analysis can be done using sampling methods sampling raw www.djpp.depkumham.go.id 2010, no. 361 114 (for example with the method √ √ n + 1, n or other statistical methods such as Military Standard 105D). Example IK Sampling of raw materials and Packaging Materials are listed in Annex VIII. 12. Examples of Product Sampling Between IK and Ruahan Products listed in Annex VIII. 13. Example IK Sampling the finished products listed in Annex VIII. 14. An example of raw material Inspection IK listed on Annex VIII. 15. Examples of Packaging Material Examination IK listed on Annex VIII. 16. Example IK Examination In Process Control (IPC) skin care/hair care/Bath Preparations listed in Annex VIII. 17. 1.2.1.2 the inspection and testing of starting materials, products, product ruahan and between the finished product according to specifications of each. 1.2.1.2.1 of raw materials. 1.2.1.2.1.1 Every raw material be tested against predetermined specifications, such as identity, purity and other requirements that have been set. 1.2.1.2.1.2 Only qualified raw materials that can be used for the production process. 1.2.1.2.1.3 raw materials that do not meet the terms of its storage as well as separated should be labeled "rejected". 1.2.1.2.1.4 raw materials are rejected should immediately be returned to suppliers or destroyed in place, to prevent the occurrence of errors. 1.2.1.2.2 Packaging Materials. 1.2.1.2.2.1 packaging Material should meet the specifications set out for example the suitability of the type of material, weight, functionality and design. 1.2.1.2.2.2 physically disabled who are critical and which have an impact on the quality of the product should be noticed. 1.2.1.2.3 the product between and Ruahan Products. 1.2.1.2.3.1 to guarantee uniformity and integrity of the batch, in the process of supervision should be done by taking a sample that represents each batch. 1.2.1.2.3.2 products that have long been stored to do repeated test against specifications when it will be processed further. 1.2.1.2.3.3 product that does not meet the specifications be investigated thoroughly and the cause of the failure must be determined. Further process of www.djpp.depkumham.go.id 2010, no. 361 115 should get the approval of the quality control Section. 1.2.1.2.3.4 product to be reprocessed should be given tagging and placed in the quarantine area to get the approval of the quality control Section. 1.2.1.2.3.5 products are rejected should be labelled "rejected" and supervised to do destruction. 1.2.1.2.4 finished product. 1.2.1.2.4.1 of each batch of products be conducted testing in accordance with the specifications set out. 1.2.1.2.4.2 Batch of products that do not meet the specifications of the finished product which is specified is given the designation of "rejected". 1.2.1.2.4.3 product that does not meet the specifications be investigated thoroughly and the cause of the failure must be determined. Further proceedings are subject to approval of the quality control Section. 1.2.1.2.4.4 product to be reprocessed should be given tagging and placed in the quarantine area to get the approval of the quality control Section. 1.2.1.2.4.5 restart process products must meet all the specifications and quality requirements of another set before sanctioned for distribution. 1.2.1.2.4.6 products are rejected should be labelled "rejected" and supervised to do destruction. 1.2.1.2.5 Supervision During processing. Supervision over processing aims to prevent the already produced products that did not meet specifications. Supervision is carried out by taking a sample, examination and testing of product produced on specific steps of the process of processing. 1.2.1.2.6 Supervision During Packing. 1.2.1.2.6.1 Only ruahan products that already meet the requirements that are allowed to be packed. 1.2.1.2.6.2 Inspection and testing during the packaging be done periodically and taken samples at least at the beginning, middle, and end of packaging. 1.2.1.2.6.3 final products already packaged and let the quarantined until sanctioned by quality control Section. www.djpp.depkumham.go.id 2010, no. 116 1.2.1.2.7 379 Restart testing of materials or products that have been approved. 1.2.1.2.7.1 Any starting materials, products and ruahan products, between products so be set a time limit in the appropriate storage. 1.2.1.2.7.2 after passing the deadline for storage, materials or products must be retested. 1.2.1.2.7.3 When an ingredient or product storage conditions are not appropriate terms be retested before use. 1.2.2. Programs and other activities related to product quality, namely: monitoring and environmental monitoring 1.2.2.1 work done are: Monitoring 1.2.2.1.1 on a regular basis against the quality of the water used in the processing of a product that is in chemistry, physics, and microbiology. 1.2.2.1.2 periodical Monitoring of the environment of the production that is, in a State of production and are not productive. Monitoring is done among others against temperature, humidity, dust particles, microbes, vibration and noise levels. 1.2.2.1.3 Surveillance against the pollution that exists around the location of the factory such as insects, birds, rodents and others. 1.2.2.1.4 Surveillance against a possible impurities from personnel who work such as not washing hands, not using gloves, do not use the mask, the dirty work clothes and others. 1.2.2.2 Assessment documentation Notes the creation of the batch. 1.2.2.2.1 all records of production and quality control of each batch of finished products be inspected by quality control Section to determine whether the manufacture of the batch in question meets all the procedures that have been set before sanctioned for distribution. 1.2.2.2.2 Each batch that deviates or fails to meet its specifications be investigated thoroughly. A written report on the investigation be made, accompanied by conclusions and follow-up. Example Batch Failure Investigations Report are listed in Appendix VIII. 18. 1.2.2.3 Monitoring Program example pertinggal. 1.2.2.3.1 example of pertinggal intended to reference the stability of the product and as a reference when receiving customer complaints. 1.2.2.3.2 In preparation of example pertinggal should note the General provisions as follows: 1.2.2.3.2.1 example of pertinggal specifically for the raw materials should be given a clear identity and stored www.djpp.depkumham.go.id


2010, no. 361 117 in tightly closed containers under the conditions set out, for at least one year after the expiration date. 1.2.2.3.2.2 pertingggal examples of finished products in the form of complete packaging as marketed that represents each batch should be stored for at least one year after the expiration date. An example of a finished product is stored in conditions similar to the conditions stated on the label. 1.2.2.3.2.3 For a finished product that has the size of a large packaging can be represented with a small packaging from the same batch with the same packaging material specifications. 1.2.2.3.2.4 pertinggal the number of examples of at least twice the amount required to complete testing. 1.2.2.3.2.5 Examination generally organoleptis be done prior to the destruction of the pertinggal example. Example Pertinggal Example Handling POB listed on Annex VIII. 19. 1.2.2.4 Monitoring product quality that was in circulation 1.2.2.4.1 existing products in circulation are monitored on a periodic basis together with the marketing. 1.2.2.4.2 monitoring Results are evaluated, documented and reported to the related parts as a feedback in doing continuous improvement. 1.2.2.5 Research Program stability. 1.2.2.5.1 let the stability research program designed to find out the stability of a product and determine a suitable storage conditions and expiry products. 1.2.2.5.2 should consider the stability of the Research Program: 1.2.2.5.2.1 batch Number batch size to a different one. 1.2.2.5.2.2 the number of examples. 1.2.2.5.2.3 testing Schedule. 1.2.2.5.2.4 storage conditions. 1.2.2.5.2.5 method of testing that is specific, meaningful and reliable. 1.2.2.5.2.6 completeness of product to be tested, at least in the same primary packaging with packaging that will be marketed. 1.2.2.5.3 stability Studies should be done in the following: 1.2.2.5.3.1 new product (generally done in batch experiments using accelerated stability test and at room temperature). www.djpp.depkumham.go.id 2010, no. 361 118 1.2.2.5.3.2 replace or supplement a different primary packaging materials with a predetermined standard. 1.2.2.5.3.3 Changes the formula, processing methods and manufacturers of raw materials. 1.2.2.5.3.4 Batch that passed with the exception of IE through processing. 1.2.2.5.3.5 For outstanding products, stability studies conducted at room temperature. Stability Test examples listed in Annex VIII. 20. Stability test report example is listed on Annex VIII. 21. 1.2.2.6 specification Assignment starting materials and finished products. 1.2.2.6.1 each of the specifications of the starting materials, products, product ruahan and between the finished product be approved and kept by the quality control Section. Things that are covered in the initial material, product specifications between product, ruahan and finished products can be seen in chapter Documentation subject specifications (Chapter IX grain 2). Periodic revisions when needed on the specifications to note other reference documents. 1.2.2.6.2 Specifications drawn up by the quality control in accordance with the data product development and level of quality desired. 1.3 is quite clear. 2. Restart Processing 2.1 re-processing methods be continually evaluated to ensure that the quality of the resulting products meet the specifications of the finished product. Re-processing a batch of a product can be considered only if it has been done an evaluation of risk. The finished product always be reset processing results monitored quality and stability. Re-processing methods be authorized specifically by head of production and quality control as well as the head of the Department should be fully documented. All changes must be recorded in the record of the batch of products. 2.2 is quite clear. 3. a refund for Product quality control Section be responsible for handling product returns because of the complaints, damages, expired or anything else that raises doubts over the quality of the product. 3.1 is quite clear. 3.2 Be carried out physical examinations and critically examined whether or not the tests need to be performed against all the products change. www.djpp.depkumham.go.id 2010, no. 361 119 return Products that still meet the prescribed specifications, may moved her status became a finished product that is sanctioned. In the event of a refund for products that will be repackaged with a new batch number is assigned a specific code. 3.3 quite clear. 2.1 is quite clear. 3.5 return product Records be stored, evaluated at regular intervals, and made feedback related to the part. Records should include the following: 3.5.1 3.5.2 product name dosage Form 3.5.3 3.5.4 batch Number Reason refund amount refunded 3.5.5 3.5.6 date of repair (if it can be fixed), and the date of destruction 3.5.7 3.5.8 extermination Method Example IK Inspection finished products, skin care, hair care, Bath Preparations listed in Annex VIII. 22. Examples of POB Handling customer complaints listed on Annex VIII. 23. Example IK Criteria customer complaints listed on Annex VIII. 24. Examples of Products listed on Withdrawal POB Attachment VIII. 25. Examples of Destruction of goods listed on the POB Attachment VIII. 26. Examples of Destruction of goods listed on the IK Attachment VIII. 27. Example of a News event of the destruction of the Goods listed in Appendix VIII. 28. Examples of application for destruction of the Goods listed in Appendix VIII. 29. www.djpp.depkumham.go.id 2010, no. 361 120 Annex VIII. 1 (example) the LAYOUT of the LABORATORY QUALITY CONTROL www.djpp.depkumham.go.id 2010, no. 361 121 Annex VIII. 2 (example) OPERATING PROCEDURES and MAINTENANCE TOOL USAGE RAW PEMBASUH EYES page 1 of 1 RAW USE of OPERATING PROCEDURES and MAINTENANCE of the TOOL PEMBASUH EYES ... ... ... ... THE COMPANY'S NAME................................. BAGIAN ............................... SEKSI ................................ Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... 1. GOALS so that employees can use the appliance in accordance with its function at the time of the accident, then the following procedures must be understood carefully. The function of the tool is to wash and clean your eyes are exposed to the chemicals. 2. PROCEDURE 2.1. The use of 2.1.1. Employees who had an accident immediately headed to the pembasuh tool. 2.1.2. Press button on the appliance until the water gushed through both penyembur. 2.1.3. Enter part of the face (eyes) are exposed to the chemicals into a gap between two penyembur and wash so clean. 2.1.4. Perform the washing and cleaning over and over until the eyes clean from chemicals. Attention: the washing/cleaning is effected vertically using clean water in order not to damage the eyes. 2.2. Maintenance of 2.2.1. The oversight tool was carried out by the security coordination has been appointed. 2.2.2. The scrutiny carried out regularly each month. 2.2.3. every supervisory oversight tool books noted in the pembasuh the eyes. www.djpp.depkumham.go.id 2010, no. 361 122 Annex VIII. 3 (example) INSTALLATION INSTRUCTIONS RESPIRATOR for ORGANIC VAPORS/ACID-page 1 of 1 INSTRUCTIONS INSTALLATION RESPIRATOR for ORGANIC VAPORS/ACID number ... ... ... ... THE COMPANY'S NAME................................ BAGIAN ............................. SEKSI ............................... Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... 1. purpose the purpose of the use of the respirator is in the instruction of this work is to protect employees who work using organic matter and volatile acids. 2. the RESPIRATOR Respirator: a special colored with a special designation. 3. HOW to USE 3.1. Put straps under respirator encircling the head slightly below the ears, if you need to loosen the straps. 3.2. place respirator on the face starting with the Paste on the Chin and then the nose. Make sure that the respirator installed properly at the nose. 3.3. Hold respirator in his position. With a free hand, check the position of the respirator with the perfection of the way of stressing a piece of cardboard on the intake of air through a sieve, and then blow hard. If the installation is correct and the position of the respirator is perfect, then the positive pressure will be felt on the inside of the respirator. If the leak, fix the position of the respirator and check back as way over the top. 3.4. After the respirator installed properly, with a free hand pairs of straps over head encircled respirator respirator while holding on to its position. Tighten the straps. 3.5. During respirator use must remain on his position. When its position changes, repeat the pairing again starting from step number 3 above. www.djpp.depkumham.go.id


2010, no. 361 123 Annex VIII. 4 OPERATIONAL PROCEDURES (example) RAW CALIBRATION of pH meters page 1 of RAW OPERATING PROCEDURES 1 CALIBRATION of the pH METER number ... ... ... ... THE COMPANY'S NAME.............................. BAGIAN ................................ SEKSI ............................... Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... 1. Purpose as guidelines for quality control officer in order to make the tool a pH meter in accordance with the required specifications. 2. PROCEDURE 2.1. Calibration of the pH meter should be done every time before use. 2.2. Make a note of the data in the log book. 2.3. Calibration of the pH level is 2 (acid or alkaline) 1.5. Making the solution Encompasses: 2.4.1. Potassium Biftalat 0.05 M Dissolve 10.21 grams of Potassium Biftalat KHC8H404 (previously dried at a temperature of 110 ° C for 1 hour) in distilled water until the right 1000 ml. 2.4.2. Ekimolar Phosphate 0.05 M Dissolve 3.533 Anhydrous Disodium Hydrogen Phosphate grams (Na2HPO4) Potassium Dihidrogen grams of 3.388 and phosphate (KH2PO4), (each substance had already been drained earlier in the 125 ° C for 2 hours) in distilled water until the right 1000 ml. 2.4.3. Sodium Borate 0.01 M Dissolve 3.8 grams of Sodium Borate (URNa2B4O7.H2O) in distilled water until the right 1000 ml. 2.5. The value of the pH of the solution encompasses raw at different temperatures: Temperature (° C) Potassium Phosphate 0.05 M Biftalat Ekimolar 0.05 M Sodium Borate 0.05 M 15 20 25 30 4.00 4.00 4.01 4.02 6.90 6.88 6.86 6.85 9.28 9.23 9.18 9.14 2.6. How to calibrate the 2.6.1. Dip the electrode in a solution of raw Phosphate and Ekimolar can be set to indicate the pH of the appropriate table (item 4) 2.6.2. Dip in solution encompasses other raw IE the acid or base is dependent requirement; and 2.6.3. pH meters are eligible if a pH reading is still within the limits of 0.05 pH unit as indicated in the table in grains 4. www.djpp.depkumham.go.id 2010, no. 361 124 Appendix VIII. 5 (example) WORK INSTRUCTIONS USING pH meters page 1 of 1 INSTRUCTIONS USING a pH METER number ... ... ... ... THE COMPANY'S NAME....................................... BAGIAN ....................................... SEKSI ........................................ Effective date ... ... ... Compiled by ... ... ... ... ... ... Date ... ... ... Review by................... Date ... .... Approved by................... Date ... ... .... Replace the number ... ... ... ... ... ... Date ... ... 1. purpose the purpose of the use of a pH meter that is meant in this procedure is to measure the pH test and perform calibration of pH meter before use. 2. PROCEDURE 2.1. Calibration of 2.1.1. Lift electrode 2.1.2. Wash to clean with distilled water that is free of carbon dioxide 2.1.3. Adjust the temperature of the solution encompasses pH 7.0 to 25 ° C 2.1.4. Dip the electrode into a pH aqueous 7.0 2.1.4.1. Rotate button "Operator Lever" to the position of "Use" 2.1.4.2. Set the hint meter by turning knob "Standardize Control" to point to the number 7 2.1.4.3. Rotate button "Operator Lever" back to "Stand By" position 2.1.4.4. Lift the electrodes; and 2.1.4.5. Wash clean with distilled water until free of carbon dioxide 2.1.5. Dip the electrode into the solution encompasses pH 4.0 or pH 10 depending on the range of the pH test (acid or alkaline). Repeat stage 4 several times until it obtained a pH reading three times consecutive in the limit beturut + 0.05 pH unit. 2.2. Measurements of the pH of the solution test 2.2.1. Adjust the temperature of the solution test be 25 ° C 2.2.2. Dip the electrode into the solution test. Rotate button "Operator Lever" to "Use". Goyangkan test solution container slowly for 2 minutes before reading. This reading is the reading of the original. Add more test solution into a container. Goyangkan container for 2 minutes then do the reading. 2.2.3. repeat stage 2 by adding more of the solution test three to four times longer. A pH reading is considered correct if the two meet following requirements: 2.2.3.1.Cappello. A reading of pH numbers within the limits of + 0.05 pH unit 2.2.3.2. When observed for 2 minutes reading does not deviate more than 0.02 pH unit. 2.2.4. Lift the electrodes, electrode cleaner to wash with distilled water free of carbon dioxide. 2.2.5. Dip the electrode in a solution that is appropriate (e.g. distilled water free of carbon dioxide) to store the electrode when discharging a pH meter. 3. The ATTENTION of the 3.1. This instrument is designed to measure the pH at a temperature of 25 ° C 3.2. Do not rotate or move the position of the other buttons except the button "Standardize Control" and "Operator Lever" 3.3. During the pH meter is not used, the "Operator's Lever" to always be in a position to "Stand By". www.djpp.depkumham.go.id 2010, no. 341 125 Annex VIII. 6 (example) RECOMMENDATION STATUS LABEL EQUIPMENT company name............................... Nama Alat : ................................... Nomor Alat : ................................... ALREADY CALIBRATED this tool was last calibrated dates: ... ... ... ... ... ... ... ... ... ...-Implementing Officers: ... ... ... ... ... ... ... ... ... ...-Restart Calibration: ... ... ... ... ... ... ... ... ... ... Signature, _ _ _ _ _ _ _ _ _ _ _ the officer Executing the COMPANY'S NAME................................... Nama Alat : ....................................... Nomor Alat : ....................................... YET these tools are prohibited from using the CALIBRATED Date signature, ... ... ... ... ... ... ... ... _ _ _ _ _ _ _ _ _ the officer who Authorized the COMPANY'S NAME............................. Nama Alat : .................................. Nomor Alat : ................................. P E R H A T I A N THIS INSTRUMENT MUST BE CALIBRATED EVERY TIME BEFORE YOU USED the date of the signature, ... ... ... ... ... ... ... ... _ _ _ _ _ _ _ _ _ the officer who Authorized the COMPANY'S NAME.............................. Nama Alat : ................................... Nomor Alat : ................................... R U S A K MUST BE REPAIRED and CALIBRATED PRIOR to signature, Date USED................ _ _ _ _ _ _ _ _ _ the officer who authorized the www.djpp.depkumham.go.id 2010, no. 361 126 Annex VIII. 7 (example) NOTE the MANUFACTURE of REAGENTS and AQUEOUS MEDIA BREEDING company name............................................................... NOTE MAKING A SOLUTION Of REACTANT And The Reactant Solution Name BREEDING MEDIA: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Media Reproduction: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... pH *) DATE the AMOUNT of MATERIAL in the INITIAL VOLUME of the END WEIGH T G L D IS TE RI LK A N K A ED L TG N W A RS A NUMBER of PROCEDURES CREATION MADE by *) just for Breeding Media www.djpp.depkumham.go.id 2010, no. 361 127 Annex VIII. 8 (example) RECOMMENDATION REACTANT SOLUTION CONTAINER LABELS and MEDIA BREEDING company name.......................................... Created by creation date storage expiration date NAME of SOLUTION of REACTANT/MEDIA CREATION........................................................................................................................................................................................................................................................................................................... SOLUTION CONTAINER LABEL RECOMMENDATIONS TITER COMPANY NAME.............................................................................. AQUEOUS solutions of Name TITER Titer Concentration is made by Way of standardising storage creation date: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Tanggal Kedaluwarsa : ....................... : .............................................................. : .............................................................. Nominal Factors Paraf www.djpp.depkumham.go.id date 2010, no. 361 128 Annex VIII. 9 (example) the SPECIFICATION of the RAW MATERIAL and PACKAGING MATERIAL SPECIFICATIONS of RAW MATERIAL Name INCHES/chemical: ... ... ... ... ... ... ... ... ... ... ... ... ... ... Nama Dagang : .......................................... No. Kode : .......................................... Referensi : .......................................... Pemerian : .......................................... Identification:.......................................... Kimia fisika : .......................................... Sampling:.......................................... Expiration:.......................................... Penyimpanan : .......................................... PACKAGING MATERIAL Supplier SPECIFICATION.................... The size/capacity of 10 g components are One of a kind, consists of aluminium foil bag of Prints On the front page, there is a coat of arms products (black), writing the name of the product, the net weight, the No. Reg, name and address of the company (blue), images (red, yellow, blue). On the back page, listed writing: composition, usage and production code, all black. The requirements of Chemical/Physical width: 65 mm height: 11 mm Weight: 4.3 g leaks, no material aluminum foil type XY. Thickness of................... How sampling See PROTAP No.................. TGL................... Storage in plastic bags in the room locked 1000 sachets Packaging in plastic bag Forms/pictures see annex www.djpp.depkumham.go.id


2010, no. 361 129 Annex VIII. 10 (example) NAME of the COMPANY: CERTIFICATE of ANALYSIS ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... NAMA PRODUK : .................................................................. The SHAPE of the MATERIAL: Soap shower NO. BETS : ........................................... Results of the TESTING Specification Description standard Odor standard Number 320 – 330 penyabunan specific gravity (25 ° c) 0.94 0.96-Viscosity (25 ° c) 28.0 cps Numbers 0.1 acidity Index Refraktif (25 oC) around 1.45 1.0 Iodine Number Description approved by, _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Ka. Part quality control ACCEPTED rejected.................../.../20 .... Testing conducted By _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Analysts www.djpp.depkumham.go.id 2010, no. 361 130 Appendix VIII. 11 OPERATIONAL PROCEDURES (example) EVALUATION and ASSESSMENT of SUPPLIERS of RAW page 1 of 2 RAW OPERATIONAL PROCEDURES EVALUATION and ASSESSMENT of SUPPLIERS number ... ... ... ... THE COMPANY'S NAME................................. BAGIAN .................................. SEKSI ................................. Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... 1. The PURPOSE to evaluate the suppliers/producers of raw materials and packaging materials, are already generating the starting materials which meet predetermined specifications. 2. SCOPE 2.1. To evaluate the performance of the suppliers of raw materials and ingredients helper. 2.2. To seek new suppliers of raw materials and ingredients helper. 3. PROCEDURE 3.1. Evaluation Of Suppliers. The responsibility of the purchasing staff (Administrative staff) include the following: 3.1.1. Record number of raw materials and auxiliary materials/filing date, judging from the receipt of the goods (TTB) made by officers of the warehouse. 3.1.2. see data from laboratory examination results form for the quality of the raw material/helper that isn't sanctioned by the QC. 3.1.3. Evaluation of suppliers is done by conducting assessment of the timeliness of the delivery of the goods, the quantity and quality of goods. 3.1.3.1. penilainnya delivery of Evaluation as follows: 3.1.3.1.1. Rated 100 if the delivery in accordance with the date requested. 3.1.3.1.2. Rated 80 if delivery is late up to 3 (three) working days from the date requested. 3.1.3.1.3. Rated 40 if delivery is late more than four (4) days of the date requested. 3.1.3.2. The evaluation of the quantity of assessment as follows: 3.1.3.2.1. Rated 100 if the amount of items ordered in accordance with a tolerance of ± 10%. 3.1.3.2.2. Rated 40 if the number of items sent more/less than of tolerating 3.1.3.3. Evaluation of the quality of his judgement as follows: 3.1.3.3.1. Rated 100 if the quality of the goods passed QC. 3.1.3.3.2. Rated 40 if the quality of the goods rejected QC. For raw materials/quality goods rejected helper QC informed to supplier corrective action request forms via so instantly drawn to reverted (returned). www.djpp.depkumham.go.id 2010, no. 361 131 page 2 of 2 RAW OPERATIONAL PROCEDURES EVALUATION and ASSESSMENT of SUPPLIERS number ... ... ... ... THE COMPANY'S NAME................................. BAGIAN ................................... SEKSI ................................ Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... 3.1.1.1. The final value obtained by finding the average of the value evaluation per month per supplier with a predicate as follows: 3.1.1.1.1. A with an average rating of 100 s/d 80 means suppliers can be maintained. 3.1.1.1.2. B with an average score of 79 s/d 60 means suppliers can be maintained with an obligation to fix it in the next period (delivered through Supplier Corrective Action Request). 3.1.1.1.3. C with an average score of under 60 means suppliers are excluded from the Approved Vendor List (AVL). Suppliers who got the predicate C for 2 (two) consecutive assessment periods will be issued from AVL, if the supplier is the sole supplier of alternative suppliers search immediately. 3.1.2. suppliers evaluation results Recap every 3 (three) months in the form of Recapitulation form evaluation of suppliers. 3.1. Assessment for the determination of the responsibility of the Suppliers of staff Administration Section Head & Purchase includes: 3.1.1. Looking for information about suppliers that can supply the required goods. 3.1.2. After getting the information, submit a new supplier qualification questionnaire and request a sample of the goods. 3.1.3. Receive the returned questionnaires and give an example to the QC for review. 3.1.4. Assessing new suppliers with the following criteria: 3.2.4.1. Accepted when: 3.2.4.1.1. Examples of items that are requested by QC passed. 3.2.4.1.2. Answers to the questionnaire the technical aspects no. 2.1, 2.2 and 2.4.1.1 & aspects of after sales service no. 2.1 must be Yes 3.2.4.2. Rejected if the answer the questionnaire as mentioned above is not and or example is not sanctioned by the QC. 3.2.4.3. Incorporate suppliers who are accepted into the AVL. www.djpp.depkumham.go.id 2010, no. 361 132 Annex VIII. 12 (example) WORK INSTRUCTIONS SAMPLING of RAW MATERIALS and PACKAGING MATERIALS page 1 of 3 INSTRUCTION WORK SAMPLING of RAW MATERIALS and PACKAGING MATERIALS ... ... ... ... THE COMPANY'S NAME........................................ BAGIAN .................................... SEKSI .................................... Effective date...................... Compiled by ... ... ... ... ... ... Date ... ... ... ... ... ... Review by................... Date ... ... ... ... ... .... Approved by................... Date ... ... ... ... ... .... Replace the number ... ... ... ... ... ... Date ... ... ... ... ... ... Person in charge: QC Analyst 1. 1.1 raw materials. Raw materials to be taken e.g. grouped according the batch/lot number is the same on each arrival. 1.2. Sampling follows the formula of n + 1 √ If n > 3; n: number of containers/packaging received example: Received 19 zak stearic acid with the same batch number, then taken examples are numerous √ 19 + 1 = + 1 = 4.4 5.4 (rounded to 5). Note: for the amount of packaging that comes

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