REPUBLIC OF INDONESIA STATE NEWS

No. 794, 2014 KEMEN KP. Fish pills. Cara Creation.

REGULATION OF MARINE AND FISHERY MINISTERS

REPUBLIC OF INDONESIA

NUMBER 24 /PERMEN-KP/2014

ABOUT

THE KIND OF GOOD FISH DRUG MAKING

WITH THE GRACE OF GOD ALMIGHTY

MINISTER MARINE AND FISHERIES OF THE REPUBLIC OF INDONESIA,

DRAWS: A. that in order to guarantee the consistency of the fish drug manufacturing process in order to meet the safety, quality, and efficacy requirements of the fish drug, it needs to set up a good fish drug-making;

b. that for that it needs to establish the Regulation of the Minister of Oceans and Fisheries on the Way of Making Good Fish Drugs;

Given: 1. Law No. 31 Year 2004 on Fisheries (State of the Republic of Indonesia 2004 number 118, Additional Gazette Republic of Indonesia Number 4433), as amended by Law No. 45 Year 2009 (State Sheet) Republic Of Indonesia In 2009 Number 154, Additional Gazette Republic of Indonesia Number 5073);

2. Presidential Decree No. 47 of 2009 on the Establishment and Organization of the Ministry of State, as amended last with the Regulation

www.peraturan.go.id

2014, No. 794 2

President Number 55 Of 2013 (state Gazette Indonesia Year 2013 Number 125);

3. Presidential Decree No. 24 of 2010 on Occupation, Duty, and Functions of the Ministry of State and Functions of the Organization, Duty, and Functions of the Ministry of State, as amended last with the Presidential Regulation No. 56 of 2013 (State of the Republic of Indonesia in 2013 No. 126);

4. Presidential Decree No. 84 /P of the Year 2009, as amended by Presidential Decree No. 41/P of 2014;

5. The Regulation of the Minister of Maritime Affairs and Fisheries of PER.04/MEN/2012 on the Drug of the Republic of Indonesia (2012 Number 139), as amended by the Ordinance of the Minister of Marine and Fisheries 14 /PERMEN-KP/2013 (News of the State of Indonesia) Republic of Indonesia in 2013 No. 893);

6. Marine Minister and Fisheries Law Number PER.15/MEN/2010 on the Organization and Works of the Ministry of Marine and Fisheries;

DECIDED:

SET: MINISTER OF MARINE AND FISHERY REGULATIONS ON HOW TO MANUFACTURE FISH DRUGS ALL RIGHT.

CHAPTER I OF THE GENERAL PROVISION

Article 1

In this Ministerial Ordinance referred to:

1. A Good Making of Fish, which is further abbreviated to CPOIB, is the guideline for regulating the entire production process that includes the activities of processing raw materials, products between, and/or bulk products (bulk) and quality supervision. It produces a safe, quality, and well-produced fish drug.

2. The Certificate of the Good Fish Drug Making, which is subsequently called the CPOIB Certificate is a caption letter stating that the fish drug manufacturer has implemented the requirements of the CPOIB.

3. Fish medication is a supply that can be used to prevent and/or treat fish disease, free symptoms of the disease,

www.peraturan.go.id

2014, No. 7943

or modifying the chemical process in a body that includes a biologic, farmasetik, premixes, probiotic, and natural remedies.

4. Fish medication is a fish-drug product consisting of biologics, pharmasetic, premixes, probiotics, and natural medicine.

5. The starting materials are all materials or chemicals that are active, additional materials and/or helper materials either in the form of a single component, ruahan/half so that it is used to make fish drugs.

6. The intermediate product is any material or mixture of materials that still require one or more advanced processing stages to be a bulk product (bulk).

7. The bulk product (bulk) is a mixture of finished raw fish drugs that still require a packaging stage to become a product.

8. Batch is a number of fish drugs that are from one production in the same time.

9. Lot is a particular part of a batch that has a uniform trait and quality within the specified limit.

10. A fish is any kind of organism that is all over or part of its life cycle in a waterway environment.

11. A quarantine is the separation of materials or products physically or with a particular system to await the outcome of the examination results whether a material or product may or may not be used for the processing, packaging and/or distribution of fish drugs.

12. Documentation is all the procedures, instructions, and written records related to the manufacture of fish drugs.

13. A fish drug manufacturer is every person who produces fish drugs from raw materials until it becomes a fish drug.

14. A person is an individual person or a fish drug company.

15. A fish drug company is a corporation that performs in the field of fish medicine whether it is a legal entity and not a legal entity.

16. The Minister is the minister who organizes government affairs in the field of fisheries.

17. The Director General is the director general carrying out technical duties in the field of cultivation fisheries.

www.peraturan.go.id

2014, No. 794 4

Article 2

The scope of the Regulation of the Minister includes:

a. Requirements; and

b. Certification.

BAB II

REQUIREMENTS

Article 3

Every fish drug manufacturer who performs the provision of fish drugs through the making in the country is obliged to apply the CPOIB requirements.

Section 4

(1) The CPOIB Requirements as referred to in Section 3 include:

a. Quality management; b. personalia; c. buildings and facilities; d. equipment; e. sanitation and hygiene; f. production; g. Quality control; h. Self inspection (internal audit) and quality audits; i. handling of complaints against products, withdrawrights

products, and change products; j. documentation; and k. qualification and validation.

(2) Quality management as referred to in paragraph (1) of the letter a consists of:

a. Quality assurance; and

b. Product quality review.

(3) Personalization as referred to in paragraph (1) the letter b consists of:

a. core personnel; and

b. personnel whose activities are affected by the product quality.

(4) The building and facility as referred to in paragraph (1) the letter c consists of:

a. the balancing area;

b. production area;

c. storage area;

www.peraturan.go.id

2014, No. 7945

d. a quality control area; and

e. supporting areas.

(5) The Appliance as referred to in paragraph (1) of the letter d consists of:

a. design and construction of equipment;

b. installation and placement; and

c. treatment.

(6) Sanitation and hygiene as referred to in paragraph (1) the letter e consists of:

a. individual hygiene;

b. sanitation of buildings and facilities;

c. hygiene and sanitary equipment; and

d. Validation of sanitary and hygiene procedures.

(7) Production as referred to in paragraph (1) the letter f consists of:

a. initial materials;

b. Process validation;

c. Cross pollution prevention;

d. batch numbering system/lot;

e. rebalancing and submission;

f. returns;

g. processing;

h. materials and dry products;

i. mixing and granulation;

j. Tablet printer;

k. fluid (non sterile);

l. material of gold;

m. the packaging activities;

n. The pre-cocodification of the gilt;

o. track readiness;

p. the packaging process;

q. the completion of the packaging activities;

r. supervision during the process;

s. the materials and products that were rejected, restored, and returned;

www.peraturan.go.id

2014, No. 794 6

t. quarantine and submission of the product so;

u. fish drug delivery control record;

v. initial material storage, gold, intermediate product, bulk product (bulk) and product so; and

w. delivery and transport.

(8) Quality supervision as referred to in paragraph (1) the g is executed following the terms of a good quality supervision laboratory (Good Laboratories Practices), consisting of:

a. buildings and facilities;

b. personnel;

c. equipment;

d. reagent and media culture;

e. default comparison/default standard;

f. specs and testing procedures;

g. analysis notes;

h. sample retrieval handling;

i. initial materials handling;

j. examination and testing of early materials, intermediate products, ruahan products (bulk), and products so;

k. the handling of the gold material;

l. environment monitoring;

m. supervision during the process;

n. retesting the dilue materials;

o. handling reprocessing;

p. evaluation of quality supervision of the production procedure; and

q. Stability testing.

(9) Self-Inspection (internal audit) and quality audits as referred to in paragraph (1) the letter h consists of:

a. Self-inspection (internal audit), including:

1) self-inspection aspect;

2) self inspection team;

3) inspection and inspection frequency;

4) report and follow-up; and

5) supplier audit and approval.

b. Quality audit.

www.peraturan.go.id

2014, No. 7947

(10) The handling of the complaint against the product, the recall of the product, and the change product as referred to in paragraph (1) of the letter i consists of:

a. complaints;

b. the recall of the product; and

c. the change product.

(11) The Documentation as referred to in paragraph (1) the letter j consists of:

a. quality management documentation; b. Personia documentation; c. documentation of buildings and facilities; d. equipment documentation; e. Sanitary and Hygiene documentation; f. production documentation; g. Quality control documentation; h. documentation of self-inspection (internal audit) and quality audits; i. mishandling of the complaint against the product, withdrawal

return of the product, and the change product; and j. Qualifying and Validation documentation.

(12) Qualifying and validation as referred to in paragraph (1) the letter k consists of:

a. Planning validation;

b. qualification;

c. prospectively validation;

d. concuren validation;

e. Retrospective validation;

f. cleanup validation;

g. control controls;

h. Revalidation;

i. validate the analysis method; and

j. type of analytical methods validated.

(13) Further provisions on the requirements of the CPOIB as referred to in paragraph (1) are listed in Annex I which is an inseparable part of this Minister's Regulation.

www.peraturan.go.id

2014, No. 794 8

BAB III

CERTIFICATION

Part Kesatu

General

Section 5

(1) Any manufacturer of fish drugs performing the provision of fish drugs through the making in the country is required to have a Certificate CPOIB of the Director General without charge.

(2) The CPOIB Certificate as referred to in paragraph (1) applies to a term of 5 (five) years.

Article 6

The CPOIB Certification is performed against any type and form of the provisions fish drugs.

Article 7

Each CPOIB Certificate can load more than 1 (one) type and form of certified fish medicine.

The Second Part

Requirements and Tata Cara Publishing CPOIB

Section 8

(1) Each fish drug manufacturer to have a CPOIB Certificate must apply in a manner written to the Director General, accompanied by the requirement:

a. Photocopy of the Fish.

B. image layout (layout) room;

c. CPOIB requirements data form; and

d. The letter of the declaration is sufficient:

1) has a professional power:

a) veterinarian or pharmacist as a technical refuer of fish medicine, for the supply of pharmasetic, premixes, biologics and/or natural remedies;

b) veterinarian, fish health expert, or pharmacist as a technical disclaimer of fish drugs, for probiotic supplies; and

2) the truth of data and information delivered.

www.peraturan.go.id

2014, No. 7949

(2) The invocation as referred to in paragraph (1) may contain more than 1 (one) types and forms of fish remedies to be certified.

(3) the CPOIB requirements data form as referred to in paragraph (1) the letter c, listed in Annex II which is an inseparable part of the Regulation of this Minister.

Article 9

(1) Based on the request as referred to in Article 8 of the paragraph (1), the Director General conducts an assessment of the documents submitted by referring to the CPOIB requirements.

(2) In terms of documents submitted in accordance with the CPOIB requirements, the field examination is conducted to verify the correctness of the submitted documents.

(3) In performing the assessment of the document as referred to in paragraph (1) and field examination as referred to in paragraph (2), the Director General may be assisted by the expert power.

(4) The Director General publishes the CPOIB Certificate or the issuer of the issuer of the CPOIB Certificate accompanied by the reason of the rejection, Twenty-five (twenty-five) days of work since the acceptance of the request. complete.

(5) Further provisions of assessment and field inspection as referred to in paragraph (1) and (2) are governed by the General Director's Rules.

(6) The Form and format of the CPOIB Certificate as referred to in the paragraph (4) is listed in Annex III which is an inseparable part of the Regulation of this Minister.

Article 10

(1) Any fish drug manufacturer which has had a mandatory CPOIB Certificate:

a. maintaining the consistency of the CPOIB requirements; and

b. report to the Director General, if there is a change in the name of a fish drug technical charge.

(2) Any fish drug manufacturer that commits a violation of the obligations as referred to a paragraph (1) letter a and/or b letter levied administrative sanction.

(3) administrative sanctions as referred to in paragraph (2) consist of:

www.peraturan.go.id

2014, No. 794 10

a. written warning;

b. freezing of the CPOIB Certificate; and

c. revocation of the CPOIB Certificate.

(4) The written warning as referred to in paragraph (3) of the letter a given the most 3 (three) times in a row, each in the longest term of 60 (sixty) calendar days.

(5) Freezing Certificate CPOIB In the case of a verse (3) the letter b is given in the most prolonged period of 180 (100) calendar days, when the end of the term of the third written warning, the producer of the fish drug is not in its obligation.

(6) The revocation of the CPOIB certificate as referred to in paragraph (3) of the letter c Given to the end of the term of the freezing time, as referred to in paragraph (5) the fish drug manufacturer does not carry out its obligations.

Article 11

(1) The Director General is monitoring the consistency of the application CPOIB requirements.

(2) The provisions of the monitoring as referred to in paragraph (1) are governed with the General Director Rule.

BAB IV

CHANGE, EXTENSION, AND REPLACEMENT

CERTIFICATE OF CPOIB

Part Parts

Changes

Section 12

The change of CPOIB Certificate is performed if there is a change:

a. owner's name, for individual manufacturers;

b. the name of the company in charge, for the manufacturer of the fish drug companies;

c. place of the company's position; and/or

d. owner's address, for a manufacturer that is individual.

www.peraturan.go.id

2014, No. 79411

Article 13

(1) Any manufacturer of fish drugs to perform a change in the CPOIB Certificate must submit a request in writing to the Director General for the cause of change, by attaching it:

a. photocopy of the CPOIB Certificate that will be made changes;

b. Proof of entitlement change, for the owner's name change, as referred to in Section 12 of the letter a;

c. as referred to in Section 12 of the letter b and the letter c; and

d. Photocopy of the Population Card, for the change of the owner's address as referred to in Article 12 of the letter d.

(2) Based on the application as referred to in paragraph (1), the Director General conducts an assessment of the requirements, which result in approval or rejection.

(3) The Director General publishes the CPOIB Certificate of Change or the renunciation of the Change CPOIB Certificate is accompanied by a reason for rejection, at most 5 (5) business days since the full acceptance of the request.

(4) The CPOIB Certificate of Change has been in effect since it was published until the expiration of the amended CPOIB Certificate.

(5) CPOIB Certificate Changes are given if the old CPOIB Certificate has been changed back to the Director General.

Second Section

Extension

Section 14

(1) The CPOIB Certificate extension may be submitted 3 (three) months before the expiration of the CPOIB Certificate is terminated.

(2) Each fish drug manufacturer to perform an extension of the CPOIB Certificate must apply to the Director General accompanied by:

a. Certificate of CPOIB Certificate;

b. The CPOIB requirements data form, in the event of a change; and

c. the data correctness statement letter and the information delivered.

www.peraturan.go.id

2014, No. 794 12

(3) The provisions of the grammar of the CPOIB Certificate as referred to in Article 9 apply mutatis mutandis to the extension of the extension of the CPOIB Certificate of extension.

The Third Section

Replacement

section 15

(1) The replacement of the CPOIB certificate may be performed if the original CPOIB Certificate is damaged or lost.

(2) Any fish drug manufacturer that will perform the replacement of the CPOIB Certificate, must submit a written request to the Director General is accompanied by a requirement:

a. The original CPOIB certificate, in the event of a broken CPOIB Certificate or a missing caption letter from the police in case of the CPOIB Certificate is missing; and

b. A non-confidential statement letter that represents the data and information that is delivered.

(3) If the request is approved, the Director General is five (five) working days since the receipt of the full application of the application. Replacement CPOIB Certificate.

bAB v

PROVISIONS

Article 16

The fish drug manufacturer can work together on providing fish drugs with other fish drug manufacturers that have a CPOIB certified factory with provision:

a. the type and form of a fish drug that will be produced equally; b. have a fish drug provision permit; and c. production is done in a plant that already has a CPOIB certificate.

BAB VI

TRANSITION provisions

Article 17

The certificate of the Good Animal Drug Creation Certificate owned by a fish drug manufacturer is declared to remain in effect until the expiration date.

www.peraturan.go.id

2014, No. 79413

BAB VII

provisions CLOSING

Article 18

The rules of the Minister are valid.

For everyone to know it, order the invitation of the Regulation of the Minister with its placement in the State News of the Republic of Indonesia.

Specified in Jakarta on 11 June 2014

MINISTER OF MARINE AND FISHERIES

REPUBLIC OF INDONESIA,

SHARIF C. SUTARDJO

Reundrased in Jakarta on date 13 June 2014

MINISTER OF LAW AND HUMAN RIGHTS REPUBLIC OF INDONESIA,

AMIR SYAMSUDIN

www.peraturan.go.id

2014, No. 794 14

ANNEX I

REGULATION OF MARINE AND FISHERY MINISTER REPUBLIC OF INDONESIA

NUMBER 24 /PERMEN-KP/2014

ABOUT

THE GOOD FISH DRUG MAKING

THE CPOib REQUIREMENT

THE MANUFACTURE Good fish drugs are a whole process in the manufacture of fish drugs in a thorough and important way to ensure the availability of high quality fish drugs. The manufacture of non-standard fish drugs is not justified due to the absence of assurances to safety, quality, and fish-drug efficacy. So (fish medicine) not only is the passing of a series of tests, but the quality must be formed into the product.

The drug mutu depends on the raw materials, the gold, the production process and the quality control, the building, the The equipment used and the personnel involved. The quality of the quality of a fish is not only on the execution of certain tests, but is made in a carefully controlled and monitored condition.

The method of Making Good Fish Drug (CPOIB) is a guideline that is the most important for the purpose of a drug.

aims to ensure the quality of the fish drugs produced according to the requirements and purposes of its use that covers all aspects of production and quality control. If required, a guideline adjustment is provided with the condition that the predetermined quality of the fish drug standards is achieved.

CPOIB as a guideline by fish drug manufacturers in the development of internal rules as required in the Producing fish drugs. The guideline does not mean to limit the development of new concepts or new technologies that have been validated and provide the Mutu Level of Revenue at least equivalent to the way listed in these guidelines. Thus the other means can be accepted throughout fulfilling the principle of this guideline.

A. Quality Management

1. Principle

Fish drug manufacturers should make fish drugs by applying quality management aimed at generating

www.peraturan.go.id

2014, No. 79415

A safe product for fish, human and environmental, quality and efficacy in accordance with its messaging document covering production processes, products so, and storage.

To achieve that goal must be implement quality policies in its implementation and require participation and commitment from all ranks within the company, supplier, and distributor. Quality management is conducted through the application of a fully designed quality assurance system and is applied properly. These activities are documented and monitored their effectiveness.

The basic element of quality management consists of:

a. Appropriate quality systems that include organizational structure, procedures, processes, and resources (human, funds, means and infrastructure, materials); and

b. Quality assurance is the systematic measure required to gain certainty with a high level of trust, so the resulting product meets the requirements that are set.

2. Quality Management Aspects

Aspects of quality management in the application of CPOIB include quality assurance and product quality restudy.

a. Quality assurance

Quality assurance is a broad concept that covers all things, both individually and collectively, which will affect the quality of the fish drugs produced. The purpose of quality assurance is to ensure that fish drugs are produced in quality and in accordance with the purpose of their use. Therefore the quality assurance is a single CPOIB beyond other factors, such as the design and development of products.

The correct quality assurance system for fish drug manufacturers ensures that:

1) the design and development of the product The fish drug is done with regard to the requirements of the CPOIB and the Good Laboratory Way (Good Laboratories Practices);

2) all production and control steps are clearly described and implement the CPOIB requirements;

3) Managerial responsibility is clearly described in the office description;

www.peraturan.go.id

2014, No. 794 16

4) arrangements are prepared for the provision, manufacture and use of the initial materials as well as the correct packaging of the material;

5) surveillance is performed against the initial materials, products between, the product ruahan during the process (in-process-controls), as well as calibration and validation;

6) the final product is processed and properly checked in accordance with the specified procedure;

7) the fish drugs are not sold or supplied before the Chief Security Officer Mutu Stating that each batch of production is created and controlled according to the requirements listed in the fish drug registration document;

8) available adequate settings in storage, distribution, and handling so capable of maintaining the quality of the fish drugs during the edar;

9) available self-inspection procedures and/or Quality audits that are periodically evaluated against the effectiveness and application of the Mutu Warranty system;

10) the suppliers of early materials and gold materials are evaluated to meet the quality specifications that the company has specified;

11) deviation is reported, investigated and noted;

12) is available the system to approve changes that impact the product quality;

13) quality evaluation of the reprocessing product; and

14) the product quality evaluation is regularly performed for the verification of process consistency and ensure the improvement of the process Continuous.

b. Product Quality Review

The product quality restudy is regularly conducted against all registered fish drugs, including export products, with the aim of proving the consistency of the process, the suitability of the initial materials specification, the material gold, and the end product, to view the trend and identify the improvements required for the process of manufacture and product. The periodic review of the product is regularly performed annually and is documented, considering the results of the previous and least detailed review:

www.peraturan.go.id

2014, No. 79417

1) Restudy of the starting materials and the gold materials used for the product, especially those supplied from a new source;

2) Restudy of the supervision during the critical and results process Final product testing;

3) Restudy of all batch that does not meet the specified specifications and the investigation conducted;

4) Restudy of all significant deviation or discregrights, related investigation, and the effectiveness of the results of remediation and prevention measures;

5) Review of all changes made to the process or method of analysis;

6) Restudy of the proposed variation, approved, or rejected from the registration document;

7) Restudy of the results unintended stability and all trends monitoring programs;

8) Restudy of all change products, complaints, and withdrawal of end products related to the product quality including the ongoing investigation;

9) A review of the results of the previous improvement in the product process or equipment;

10) Restudy of post marketing commitments, performed on a new end product obtaining registration approval;

11) qualifying equipment of the relevant means and its use such as the system of the system air and coolant (Heating Ventilation Air Conditioning/HVAC), water, pressurized gas, and other-lain; and

12) Restudy of the technical agreement to ensure it is always updated.

B. Personia

1. The principle

Human resources are essential in the application of quality assurance systems and good fish drug-making. Therefore, fish drugs manufacturers are responsible for providing adequate amounts of qualified personnel to carry out all tasks. The responsibility of each personnel must be clear and understood as well as recorded.

www.peraturan.go.id

2014, No. 794 18

2. General

The provisions of the personalia as follows:

a. Fish drug manufacturers have competent personnel in an adequate amount, and are not saddled with excessive responsibility to avoid risk to the quality of fish drugs;

b. Responsible personnel have a specific recorded task description and adequate authority to carry out its responsibilities;

c. such tasks may be delegated to representatives who have an adequate level of qualification;

d. Fish drug manufacturers have organizational structures to avoid gaps or overlap in the responsibility of personnel related to the application of CPOIB;

e. every personnel should pay attention to the CPOIB requirements, get early and ongoing training including hygiene instructions that are appropriate to the need;

f. every personnel should be given motivation for the development and maintenance of high performance standards; and

g. any action must be made to prevent unentitled people from entering the production area, storage and quality control areas. Non-essential personnel are prohibited from entering an area that is not in compliance with the task.

3. Core Personnel

The core personnel include the Chief of Production, the Chief of the Mutu Supervision, and the Chief Management Officer of Mutu (Pentian Mutu). The core personnel must be held by a permanent employee. The head of the Production Section, the Head of the Mutu Surveillance Section, and the Chief Management Officer of Mutu (Pentian Mutu) must be independent one against the other.

a. Head of Production Section

1) Qualifying:

a) registered and qualified pharmacist or pharmacist and has a competency certificate;

b) for the type of biologics and probiotics, the Head of Production Part can be held by a fish health expert who has a competency certificate;

c) obtained appropriate training; and

d) has adequate practical experience in the field of fish drug creation and skills

www.peraturan.go.id

2014, No. 79419

managerial so it is possible to perform professional duties.

2) The authority and responsibility:

a) ensures that the fish drugs are manufactured and stored according to the procedure to meet the specified quality requirements;

b) provide job guidance approval related to production and ensure that the work directions are applied appropriately;

c) ensure that production records have been evaluated and placed on the IBM Cloud Service. handle by the Chief of Production prior to being submitted to the Chief of the Mutu Management Section (Quality Assurance);

d) examines the maintenance of buildings and facilities as well as equipment in the production section; and

e) ensure that initial and continuous training for personnel in its department is exercised and applied accordingly. needs.

The Head of Production Section along with the Head of the Mutu Surveillance and Technical Responds has a shared responsibility for the quality related aspects.

b. Head of Quality Control

1) Qualifying:

a) registered and qualified pharmacist or pharmacist as well as having a competency certificate;

b) for the type of biologic and probiotic supplies, the Head of the Mutu Surveillance Section can be held by a fish health expert who has a competency certificate;

c) obtain the appropriate training;

d) has an adequate practical experience; and

e) has managerial skills so it is possible to Perform professional tasks.

2) Privileges and Liability:

a) approve or reject initial materials, gold materials, intermediate products, ruahan products and products so;

www.peraturan.go.id

2014, No. 794 20

b) ensuring that all necessary testing has been implemented;

c) grants consent to specifications, work directions, sampling methods, testing methods, and other quality supervising procedures;

d) grants consent and monitors all analysis contracts;

e) examines the maintenance of buildings and facilities as well as equipment in the quality control section;

f) ensures that appropriate validation has been implemented; and

g) ensuring that the initial and continuous training for personnel in his department exercised and applied as needed.

c. Head of the Quality Management (Quality Instiner)

1) Qualifier:

a) registered and qualified pharmacist or pharmacist and has a competency certificate;

b) for the type of biologic and probiotic supplies, the Chief Quality Management (Quality Insters) can be held by a fish health expert who has a competency certificate;

c) obtain the appropriate training;

d) has an adequate practical experience; and

e) has skills managerial thus allowing for professional performing tasks.

2) Authorization and Responsibility:

a) ensuring the application, and if needed to form a quality system;

b) participate in or initiated the establishment of a company quality reference;

c) initiated and supervised an internal audit. or periodic self-inspection;

d) conduct surveillance on the function of the Mutu Surveillance section;

e) initiated and participated in the execution of an internal audit;

www.peraturan.go.id

2014, No. 79421

f) initiated and participated in the validation program;

g) ensuring the fulfillment of engineering requirements or regulations relating to the quality of fish drugs;

h) evaluate or review the records batch; and

i) pass or reject the product so for sale by considering all related factors.

Each Head of Production, Head of the Mutu Surveillance Section, and Head of the Mutu Management Section (Mutu Revenue) have a shared responsibility in applying all aspects related to quality, which includes:

a. authorizing written procedures and other documents including the amendment;

b. the monitoring and control of the fish drug-making environment;

c. sanitation and plant hygiene;

d. Process validation;

e. training;

f. approval and monitoring of suppliers of materials;

g. assignment and monitoring of the storage conditions of materials and products;

h. record storage;

i. Fulfilment monitoring of CPOIB requirements;

j. inspection, investigation, and sampling; and

k. monitoring factors that may impact the quality of the product.

If there is not sufficient personnel available, then the position of Chief of the Mutu Surveillance can be as Head of the Management Section of Mutu (Revenue Mutu).

4. Personnel whose activities are influential in the product quality

a. All personnel who serve in the production area, storage storage, or laboratory (including engineering personnel, care and cleaning personnel), and for other personnel whose activities may impact the quality of the product are provided with the training.

b. In addition to basic training in CPOIB theory and practice, new personnel gets training according to the task that

4. Training ...

www.peraturan.go.id

2014, No. 794 22

given. Continuous training is also provided, and the effectiveness of the application is assessed periodically. The training program approved of each of the respective sections and records against the training is stored. Specific training is given to personnel who work in hazardous areas of the pollution, such as clean areas or high-risk materials handling areas, toxic, or sensitisation.

c. The concept of quality assurance and all appropriate measures to improve understanding and application are discussed in depth during training.

d. The training is provided by a competent and qualified person.

C. Buildings and Facilities

1. The principle

Building and facility for the manufacture of fish drugs has adequate design, construction, and layout, as well as adjusted condition and is well cared for to make it easier to operational. The layout and design of the room must be made appropriately to reduce the risk of errors, crosswords, buildup of dust or dirt, and other impacts that can decrease the quality of fish drugs.

2. Generic

a. The building was designed to avoid contamination from surrounding neighborhoods, such as contamination from air, soil, and water and from other adjacent manufacturers. If the location of the building is not appropriate, it is taken effective preventive measures against the contamination.

b. Buildings and facilities are designed, constructed, equipped, and properly cared for, to obtain the utmost protection from weather, flood, soil, and enter and nest of insects, birds, rodents, fleas, or animals. Another. There are procedures for rodent control and pest control.

c. The building and the facility are being treated carefully. The building as well as the facility is cleared and is urged to be infected according to detailed written procedure.

d. Entire buildings and facilities including production areas, laboratories, storage areas, corridors and environments

www.peraturan.go.id

2014, No. 79423

around the building is treated in clean and tidy conditions. Building conditions are regularly reviewed and fixed in the event of damage. Repair and maintenance of the building and the facility were carefully conducted so that the activity did not affect the quality of the fish.

e. Electric power, light lighting, temperature, humidity, and fentilation are installed precisely so that it does not result in adverse impacts either directly or indirectly against the product during the process of making, storage and/or accuracy the precision of the function of the equipment.

f. Design and space layout ensure:

1) compatibility with other production activities that may be carried out in the same means or adjoining means; and

2) The prevention of production area is utilized as a past path Common traffic for personnel and materials/products, or as a repository of materials or products other than those that are being processed.

g. Preventive measures are taken to prevent an influx of uninterested personnel. The production area, storage area, and quality surveillance area should not be used as a traffic lane for personnel who do not work in the area.

h. The activities below are performed in the specified area, consisting of:

1) the receipt of the material;

2) the quarantine of the entrance;

3) the storage of the initial materials and gold materials;

4) the balancing and submission of materials or products;

5) processing;

6) equipment washing;

7) equipment storage;

8) packaging;

9) quarantine of the product so before acquiring final callers;

10) product delivery; and

11) the laboratory Quality control.

www.peraturan.go.id

2014, No. 794 24

3. The balancing area

The balancing area is made up of:

a. Initial material rebalancing area; and

The initial material balance is performed in a separate balancing area designed specifically for balancing activities. The balancing area can be part of the storage area or production area.

b. The ruahan product rebalancing area.

The rebalancing of ruahan products must be done in the mixing area (mixing) in the production area.

4. Production Area

a. To further risk serious medical hazards due to cross-crossing, biologic products are produced in separate buildings.

b. The manufacture of products classified as toxic such as pesticides should not be carried out at the means of production of fish drugs.

c. The layout/layout of the production space is best designed:

1) for production activities to be performed in interconnected areas between one room with another room following the order of the production stage and according to the cleaning class. required;

2) the area of production space must be adequate in accordance with production capacity;

3) to streamline effective communication and supervision.

d. Provided a large area for workspace, material storage area, product storage area in the process, and product storage area in accordance with the flow of processes and placement of the equipment, so as to scale the risk of taking place. Errors between fish drug products or different fish drug components, preventing cross-crossing and risking their widest risk or mistaking the stages of production or surveillance.

e. Wall surfaces, floors, and inner ceilings of the rooms where there are raw materials and primary gold materials, the products between or the product of the ruahan exposed to the environment must be smooth and slippery, cracked free and the connection is open, no releasing the particles, as well as possible

www.peraturan.go.id

2014, No. 79425

The execution of cleaning (if it needs to be disinfected) is easy and effective.

f. The construction of the floor in the processing area is made of waterproof material, flat surface, and allows rapid and efficient cleaning in the case of a material spill (for example: epoxy). The angle between the wall and the floor in the processing area is arch-shaped.

g. Pipes, lampposts, ventilation points, and other means of support are designed and installed to avoid the formation of a niche that is difficult to clean. For treatment purposes, installation of such support means can be reached from outside the processing area.

h. The indoor plumbing should not be attached to the wall but is dignated by using elbows at enough distance to ease the thorough cleaning.

i. The installation of roof frames, pipes and airways in the room was avoided. If it is inescapable, the procedure and cleaning schedule of the installation are created and followed.

j. The airhole goes in and out and the pipes and the channel are fitted properly to prevent contamination of the product.

k. The aqueducts must be large enough, designed and equipped with a control tub as well as good ventilation to prevent the reverse flow. Installation of open channels is prevented but if it is needed to be installed shallow enough to ease the cleaning and disinfection.

l. Production area vents are installed effectively using air control systems, including air filters with an efficiency level that prevents pollution and cross-contamination.

m. Temperature and humidity controllers are installed according to the needs of processed products and activities carried out in the room and its impact on the outside of the factory environment.

n. The production area is monitored regularly both during there and there are no production activities to ensure fulfillment of the previously designed product specifications.

o. Room/area hygiene levels for drug making should be classified according to the maximum amount

www.peraturan.go.id

2014, No. 794 26

Air particulates allowed for each cleaning class according to the table below:

Particular size

Class

Nonoperational Operational

The maximum number of particles/m3 allowed

≥ 0.5 µ m ≥ 5 µ m ≥ 0.5 µ m ≥ 5 µ m ≥ 5 µ m

A 3,520 20 3,520 20

B 3,520 29 352,000 2,900

C 352,000 2,900 3.520,000 29,000

D 3,520,000 29,000 Not specified

Not specified

E 3.520,000 29,000 Not specified

Not specified

Attraction:

1) Class A, B, C and D are classes space hygiene for the manufacture of sterile products.

2) Class E is the cleanliness of space for the manufacture of nonsterile products.

3) Other rooms that are not classified according to the classification above, are protected at level Necessary protection.

p. Areas to perform activities that create dust, e.g. sampling, rebalancing of materials or products, mixing and processing of materials or products, packaging of powdery products, requires a special means of support to prevent cross-contamination. and make it easier to purge.

q. The layout of the packaging area space is designed specifically to prevent the mixing of products and polluters.

r. The production area gets an adequate illumination, especially where visual surveillance is performed at the time of the running process.

s. Supervision during the process can be carried out within the production area as long as the activity does not pose a risk to the production of fish drugs.

t. The doors of the production area related to the outside environment, for example, the fire danger door is always closed. Door

www.peraturan.go.id

2014, No. 79427

It is secured so that it can only be used in an emergency as the door outward. The doors inside the production area that serve as a barier for cross-contamination are always closed if they are not in use.

5. Storage Area

a. The storage area has an adequate capacity to store well-neatly and regularly a wide variety of materials and products, such as starting materials, gold materials, products between, ruahan products, products in quarantine status, products so that have been passed, rejected products, products returned, or products withdrawn from the circulation.

b. Storage areas are designed or adapted to guarantee good storage conditions. The area must be clean, dry, and gets sufficient illumination and is maintained within the specified temperature and humidity limit.

c. If required special storage means (temperature and humidity settings), then it is prepared, controlled, monitored, and noted.

d. The reception area and delivery of the goods are designed and equipped with customised equipment for the cleaning of the goods container.

e. If a quarantine is performed by a storage in a separate area, the area must be provided with clear tagging and access to the area is limited to authorized personnel. Other systems to replace the physical quarantine system can physically be done with the requirement of providing equivalent security.

f. Provided a separate area with a controlled environment for initial material sampling. If the activity is done in the storage area, the sampling is made to prevent contamination or pollution. An adequate cleaning procedure for sample retrieval rooms is available.

g. A separate and locked area is provided for the storage of rejected materials and products, which are retracted, or returned.

h. Early-risk materials such as KMnO4, formaldehyde, peroxide are stored in separate and locked premises.

i. Special attention is given in the storage of gold-printed material to be assured of its safety, given the gold-printing material is a critical ingredient because

b. Area ...

www.peraturan.go.id

2014, No. 794 28

states the truth of the product according to its presupposition. The label is stored in a locked place.

6. Quality Surveillance Area

a. A separate quality surveillance lab from the production area. The biological and microbiology testing area is separated.

b. The quality surveillance laboratory is designed according to the activities. The space area is adequate to prevent diffuse and cross-contamination. Provided with an adequate storage area for sample, the default comparison (if necessary with controlled temperature), solvent, reagent and record.

c. If required, a separate room is provided to provide instrument protection against electrical interference, vibration, excessive moisture and other disorders, or isolate the instrument.

d. Laboratory design pays attention to the suitability of used building materials, ventilation, and prevention of smoke or dust. Air supply to the laboratory is separated from supply to the production area. Installed a separate airbender unit for each biological and microbiology laboratory.

7. Supporting Area

a. The rest room and the cafeteria are separated from the production area and quality surveillance laboratory.

b. The means to change work clothes, clean up, and toilets are provided in sufficient quantities and easily accessible. Toilets should not be directly related to the production area or storage area. The dressing rooms are directly related to the production area but are located separately.

c. The location of the repair and maintenance workshop is separate from the production area and provided a room or special cabinet for the storage of the device.

d. The means of maintenance of fish and/or other animals are well isolated against other areas and are equipped with separate entrances (access to fish and/or other animals) as well as separate airbending units.

b. Sar a ...

www.peraturan.go.id

2014, No. 79429

D. Equipment

1. Principle

The equipment for the manufacture of fish drugs has the right design and construction, adequate size, and placed and qualified properly, in order for the quality of the fish to be guaranteed according to the design as well as the uniform of batch to batch and to ease cleaning as well as care.

2. Design and Construction

The design and construction of equipment must meet the requirements as follows:

a. The equipment is designed and constructed according to its purpose.

b. The surface of the equipment that comes into contact with the initial material, the intermediate product, the product of the ruahan or the product so must not cause a reaction, addition, or absorbance that may affect the identity, quality, or purity outside of the specified limit.

c. Materials determined for the operation of special tools, such as lubricants or coolants should not come into contact with the material being treated so as to not affect the identity, quality or purity of the initial materials, the intermediate product, or the product.

d. Equipment should not damage products due to leaking valves, lubricating droplets, and similar items or due to an untimely repair, treatment, modification, and adaptation.

e. The equipment in the design is so easy to clean. Such equipment must be cleared according to detailed written procedures as well as stored in a clean and dry state.

f. The washing and cleaning equipment was chosen and used not to be a source of pollution.

g. The equipment used is not bad for the product. The part of the device that comes into contact with the product should not be reactive, additive, or absorptive that can affect the quality and bad effect on the product.

h. All specialized equipment for the processing of flammable materials or chemicals or placed in an area using flammable materials, fitted with an explosive electrical apparatus that is explosically planted and planted into the ground correctly.

www.peraturan.go.id

2014, No. 794 30

i. Available weighted tools and measuring devices with the right range and precision for the production and supervision process. The equipment used to weigh, measure, check, and record its accuracy and calibration is calibrated according to the programs and procedures specified. The results of the examination and calibration are noted and stored well.

j. The liquid filter used for the production process does not release the fiber into the product. The filter containing asbestos should not be used although it is filtered back again using a special filter that does not release the fiber.

k. The distilled water pipe, de-ionization water, and if necessary water pipes for the production of the disanitation according to the written procedure. The procedure contains details of the microbial spruce boundary and the action to be performed.

3. Installation and Placement

a. The equipment is placed precisely to allow the possibility of cross-contamination between materials in the same area and avoid the risk of misrepresentation or pollution.

b. Each other's equipment is placed at a sufficient distance to avoid trouble and ensure a misrepresentation and mix of products.

c. All belts (belt) and pulley mechanically open are equipped with safety.

d. Water, steam, pressurized air, or vacuum as well as other channels are installed to be easily accessible at any stage of the process. The pipe is given a clear tagging to show the content and direction of the flow.

e. Each of the main equipment is marked with a clear identity number. This number is listed in all the commands and batch notes to indicate the unit or equipment used in the creation of the batch unless the equipment is used only for one product type only.

f. Damaged equipment is removed from the production area and quality oversight, or given a clear tagging.

www.peraturan.go.id

2014, No. 79431

4. Treatment

a. The equipment is treated as scheduled to prevent malfunctions or contamination that may affect the identity of the quality or purity of the product.

b. Repair and treatment activities do not pose a risk to product quality.

c. The cooling materials, lubricants, and other chemicals such as the temperature of the temperature testers are evaluated and agreed with a formal process.

d. The written procedure for the maintenance of the equipment is made and adhered to.

e. The execution of the care and use of a main tool is recorded in the tool log book which shows the date, time, product, strength, and number of each batch or lot that is processed with the tool. Notes for the equipment used specifically for one product only can be written in batch.

E. Sanitation and Hygiene

1. The principle

High levels of sanitation and hygiene are applied to every aspect of the manufacture of fish drugs. The scope of sanitation and hygiene includes personnel, buildings, equipment and supplies, production materials as well as its vessel, and everything that can be a source of the pollution of the product. Potential pollution sources are eliminated through a thorough and unified hygiene and hygiene program.

2. Individual Hygiene

a. Any personnel that entered into the making area wore protective clothing that fit the activities it was doing.

b. Individual hygiene procedures include requirements for wearing protective clothing to be applied to all personnel entering the production area, either the full-time employee, part-time or not the employee who is in the factory area, for example employees contractors, visitors, senior management members, and inspectors.

c. To ensure the product protection of the pollution and for the safety of personnel, personnel wear clean protective clothing and in accordance with its duties included

www.peraturan.go.id

2014, No. 794 32

Hair cover. Dirty work clothes and dirty cleaning naps (which can be reused) are kept in a closed container until the washing time.

d. Detailed hygiene programs were created and adapted to a variety of needs within the manufacturing area. The program includes procedures related to health, hygiene practices, and protective clothing personnel. Procedures are understood and are strictly adhered to by each personnel serving in the area of production and surveillance. The hygiene program was promoted by management and discussed widely during training sessions.

e. All personnel underwent health checkups at the time of their recruits. The manufacturer must be responsible for the available instructions which ensure that the health of the personnel's health may affect the quality of the product is notified to the manufacturer's management. After an initial health examination, occupations of occupations and medical personnel are regularly tested. The visual officer underwent an eye exam periodically.

f. All personnel apply a good individual hygiene. All personnel are trained on the application of individual hygiene. All personnel associated with the manufacturing process are paying attention to the high level of individual hygiene.

g. Any personnel who have a disease or suffer open wounds that can harm the quality of the product are prohibited from handling the starting materials, the gold, the ingredients are being processed and the fish medicine so until he is recovered.

h. Each personnel report to a direct superior of the state (factory, equipment, or personnel) that their assessment may adversely affect the product.

i. A direct touch between the operator ' s hands with the starting material, the intermediate product, and the open space products, as well as with parts of the equipment that are in contact with the product

is hinted.

j. Each personnel should wash their hands before entering the production area. For that purpose it needs to be installed a corresponding marking (poster or banner).

k. Smoking, eating, drinking, chewing, nurturing plants, storing food, drinks, ingredients for smoking, or personal medicine is only allowed in certain areas and is prohibited

i. P rtouch ...

www.peraturan.go.id

2014, No. 79433

in the production area, laboratory, warehouse area, and other areas that may have an impact on the quality of the product.

l. Non-interested guests or personnel may not enter the production area and the quality surveillance laboratory. If it cannot be avoided, guests or personnel are given an explanation first, especially regarding the personal hygiene and protective clothing that is required and closely monitored.

3. Sanitation Building and Facilities

a. The building used for the manufacture of fish drugs was designed and contrasted appropriately to make it easier for good sanitation.

b. A means of toilet with good ventilation and a washing site for personnel is available in sufficient quantities and is easily accessible from the manufacturing area.

c. Provided a means of storage of personnel clothes and private property in the right place.

d. Preparation, storage, and consumption of food and beverages are provided in special areas, for example the cafeteria. Such means must meet the sanitary standards.

e. Garbage can't be allowed to pile up. The garbage is collected in a suitable container to be moved to a shelter outside the building and dumped periodically with regard to sanitary requirements.

f. Rodenticides, insecticides, fungicides, fumigation agents, and sanitary materials should not contaminate the equipment, the starting material, the material of the gold, the material being processed or the product so.

g. There must be a written procedure for the use of rodenticides, insecticides, fungicides, fumigation, cleaners, and proper sanitation. The written procedure is composed and adhered to preventing contamination of equipment, early materials, fish drug containers, container caps, gold, and labeling or so. Rodenticides, insecticides, and fungicides are not used unless they are already registered and used according to related regulations.

h. There must be a written procedure that shows the responsible for the sanitation and elaborates in detail about the schedule, methods, equipment, and cleaning materials that must be used for the cleaning of the means and buildings. The related written procedure is adhered to.

www.peraturan.go.id

2014, No. 794 34

i. The sanitary procedure applies to the work executed by a temporary contractor or employee and full-time employee during an ordinary operational job.

j. It is forbidden to carry out unhygienic activities in the manufacturing area or other areas that may adversely affect the quality of the product.

4. Hiegene and Sanitation Equipment

a. After use, the equipment must be cleared out of the outside and its interior according to the established procedure, as well as being guarded and stored in clean conditions. Each prior to use, the hygiene of the equipment is checked to ensure that all products or materials of batch have previously been eliminated.

b. The method of cleaning by vacuum or wet way is more recommended. Pressurized and brushless air is used with caution and may be avoided as it increases the risk of a product contamination.

c. The cleaning and storage of the equipment that can be moved-moved and storage of cleaning materials is carried out in a separate room from the processing room.

d. A detailed written procedure for cleaning and sanitation equipment as well as the containers used in the manufacture of fish drugs are made, validated, and adhered to. The purpose of this procedure is to avoid the pollution of equipment by cleaning agents or sanitation. This procedure at least includes the responsible cleaning, schedule, methods, equipment and materials used in the cleaning as well as the dismantling method and the reassembly of the equipment to ensure the correct cleaning is implemented. In addition, the procedure also involves the sterilization of equipment, the removal of the previous batch identity, as well as the protection of equipment that has been cleansed against the pollution before it is used.

g. All materials and products are stored regularly on conditions suggested by the manufacturer's factory and are set to exist between batch and batch splitting and make it easier for stock rotation.

h. Examination of the amount of real results and reconciliation was made to ensure no deviation from the limit had been set.

i. Different product processing should not be performed simultaneously or alternately in the same workspace unless there is no risk of diffuse or cross contamination.

www.peraturan.go.id

2014, No. 794 36

j. Every stage of processing, products and materials is protected against microbial pollution or other pollution.

k. In conducting activities with materials or dry products, it is conducted special measures to prevent the spread and the onset of dust. This is mainly done on the handling of very active materials or causing sensitisation.

l. During processing, all materials, bulk product containers, equipment, production machines and/or workspaces are used to be labeled or tagging of processed products or materials, power (if any) and number batch. This tag is also mention stages of the production process.

m. The label on the container, the tool, or the room is made clear, does not mean double and with a set format. Colorful labels are often very helpful to show status (for example: quarantine, diluted, rejected, clean and others).

n. The examination is conducted to ensure the pipeline and other tools for the transfer of products from one to other places that have been properly connected.

o. Deviations against instruction or procedure may be avoided. In the event of a deviation then there is a written statement from the Head of the Mutu Warranty and may involve the Mutu Surveillance Section.

p. Access to buildings and production facilities is restricted only to authorized personnel.

q. Production of non-drug products is made in different areas and equipment for fish drug products.

3. Initial Materials

a. Procuring the initial materials from the approved supplier and meet the relevant specifications.

b. All receipts, expenses, and the remaining amount of materials must be noted. Note containing information about supply, number batch/lot, date of receipt or submission, date of the expiration and date of expiry if any.

c. Before being passed for use, each starting material meets the specifications and is labeled with the name stated in the specification. An unofficial abbreviation, code, or name is not used.

d. Each receipt or batch of the initial material is given a referral number that will indicate the identity of the delivery or batch during storage and processing. That number

www.peraturan.go.id

2014, No. 79437

listed clearly on the container label to allow access to the full record of the delivery or batch that will be checked.

e. If in one shipment there are more than one batch then for sample retrieval, test and graduation purposes, it is considered a separate batch .

f. In each receipt is a visual examination of the general condition, the integrity of the container and its seal, the ceceran and the possibility of material destruction, and about the compliance of the shipping records with the label of the supplier. The sample was taken by the Mutu Surveillance personnel.

g. The origin of the sample sample the initial material was taken was labeled that made it easier to identify.

h. The initial material sample must be tested according to specifications. Under certain circumstances, the partial or overall fulfillment of the specification may be shown with a certificate of analysis reinforced with the identity of the self-made identity.

i. Ensure that all containers on a shipment contain the correct initial materials, and perform security against the possible mistagging of the container by the supplier.

j. The initial material received was quarantined until approved and passed for use by the Mutu Watch Chief.

k. The initial material in the storage area is labeled the right one. The least label contains the following description:

1) the name of the material and if it needs the source code number;

2) the number batch/controls are given at the time of receipt of the material;

3) the status of the material (e.g., quarantine, is being tested, Graduated, rejected);

4) expiry date or date of trial if necessary; and

5) if the storage system uses a complete validated computerization, then all of the above information does not need to be made in the form of writing that read on the label.

l. The label that indicates the status of the initial material was affiated by the personnel appointed by the Chief of the Mutu Surveillance. To prevent errors, the label differs from the label used by the supplier, for example by listing

www.peraturan.go.id

2014, No. 794 38

company name or logo. If the status of the material is changed, the status pointer label is also changed.

m. Initial material supplies are checked periodically to reassure that the container is tightly sealed and labeled correctly and in good condition. They are subject to sampling and retesting periodically according to the specified specifications. The execution of reshoots begins with retrial lebel and/or by using the same documentation system as effective.

n. Initial materials especially those that can be damaged due to heat exposure, are stored in a room where the air temperature is tightly controlled.

o. The material that is sensitive to moisture and/or light is stored properly in the room controlled by its condition.

p. The submission of the initial material for production must be performed only by personnel authorized in accordance with the approved perosedur. The material inventory records are stored well for the reconciliation of supplies to be done.

q. A weighted device must be calibrated every day before it is used to prove that capacity, precision, and accuracy meet the requirements according to the amount of material to be weighed.

r. All of the rejected starting materials are provided with a tagging, placed separately, and destroyed or returned to the suppliers.

4. Process Validation

a. The validation of validation strengthates the execution of the CPOIB and is performed according to the established procedure. The results of validation and conclusions are noted.

b. Before a master processing procedure is applied, a step is taken to prove the procedure is suitable for the execution of a routine product, and a process that has been established using determined materials and tools. will produce a product that meets quality requirements.

c. Meaningful changes in the process, equipment, or materials are accompanied by a revalidation measure to ensure that such changes will continue to produce products that meet quality requirements.

www.peraturan.go.id

2014, No. 79439

d. Regularly validation and/or review are critical of the production process and procedures to ensure that the process and procedure are still able to provide the desired results.

5. Cross Contamination

a. The pollution of the initial materials or products by materials or other products must be avoided. The risk of this cross-contamination can arise from the unannounced control of dust, gas, steam, spark, or organism from the material or products that are being processed, from the remainder left on the device and the work garment of the operator. The risk of contamination depends on the polluting of pollutants and contaminated products. Among the most dangerous pollutants are materials that can give rise to strong sensitisation, biological preparations containing living microbes, certain hormones, cytotoxic materials, and potentially high other materials. The product affected by the pollution is a parenteral supply, a supply given in large doses and/or supplies given in a long period of time.

b. Every stage of the process, products and materials are protected against microbial pollution and other pollution.

c. Cross-contamination is avoided by the appropriate technical actions or settings, for example:

1) production in a separate building (required for products such as penicillin, sex hormones, certain cytotoxic, living vaccines, and the supply of products). living bacteria and other biological products as well as blood products);

2) available air buffer space and air suction;

3) narrowed the risk of pollution caused by recalculating air or untreated air entry. or adequate air treated adequately;

4) wear suitable protective clothing in areas where products at high risk of cross-pollution are processed;

5) carry out the proven cleaning and decontamination procedures, as the cleaning of ineffective tools is generally a source of cross-pollution;

6) uses the self-containedsystem; and

7) test residues and use the hygiene status label on the tool.

materials ...

www.peraturan.go.id

2014, No. 794 40

d. Preventive measures against cross-contamination and effectiveness are examined periodically according to the specified procedure.

6. Batch/Lot system

a. A system that describes in detail the batch/lot with the purpose of ensuring that each batch/lot of a product between, the product of the space, or the product can be identified.

b. The batch/lot's numbering system is used in the processing stage and the packaging stage is related.

c. The batch/lot of the numbering system guarantees that the same batch/lot number is not reused.

d. The allocation of the batch/lot number is immediately noted in a log book. The note includes the date given the number, product identity and size of batch/lot in question.

7. Balancing and Rebalancing

a. The balance or calculation and submission of early materials, gold, intermediate products, and ruahan products are considered to be part of the production cycle and require complete documentation and reconciliation. Control over the expenditure of such materials and products for the production of warehouses, submission area, or intersection of production is very important.

b. Way handling, balancing, counting, and submission of early materials, gold-packing materials, anathara products, and ruahan products are covered in written procedures.

c. All initial material expenditures, gold, intermediate products, and ruahan products including additional materials that have been submitted previously to the production are properly documented.

d. Only the initial materials, the gold, the intermediate products, and the ruahan products that the Mutu Oversight has passed and still have not expired that may be handed over.

e. To avoid the occurrence of diffuse, cross-contamination, identity loss and doubt, then only the initial material, the product between and the associated ruahan product of a single batch alone may be placed in the submission area. After balancing, submission and tagging, initial materials, intermediate products, and ruahan products

www.peraturan.go.id

2014, No. 79441

is transported and stored in a correct way so that its tenacity remains awake until the next processing.

f. Before balancing and submission, each preliminary material container is examined for the truth of its inclusion, including the acceptance label of the Mutu Surveillance section.

g. Capacity, precision, and precision of weighted instruments and measuring devices are used according to the amount of material weighed or root.

h. For each balance or measurement, the identity of the identity and the number of material is weighed or measured by two independent personnel, and the proof is noted.

i. The weighted room and the handover are kept clean. The initial sterile material to be used for sterile products is weighed down and handed over in the sterile area.

j. Balancing and submission activities are performed using appropriate and clean equipment.

k. The initial materials, intermediate products, and ruahan products were handed rechecked the truth and were signed by the production supervisor before being sent to the production section.

l. Once weighed and counted, the material for each batch is stored in a single group and given a clear tagging.

8. Return

a. All of the initial materials, gold materials, intermediate products, and ruahan products returned to the storage warehouse are properly documented and reconciled.

b. The starting materials, the gold, the product between and the ruahan product are not returned to the storage shed unless it meets the specified specifications.

9. Processing

a. All the ingredients used in the processing are checked before use.

b. Different product creation activities should not be performed simultaneously or sequentially in the same space, unless there is no risk of diffuse or cross-contamination.

www.peraturan.go.id

2014, No. 794 42

c. Environmental conditions in the processing area are monitored and controlled to always be at the level required for processing activities. Before processing activities are taken steps to ensure the processing area and equipment are clean and free from the initial materials, products, or documents that are not required for the processing actions performed.

d. All the equipment used in the processing is checked before use. The equipment must be clean and stated in writing before it is used.

e. All processing activities are conducted following the written procedure. Every deviation is accounted for and reported.

f. Containers and caps are used for materials to be processed, products between and clean-space products and are made from the right materials of nature and its kind to protect the product or material against the pollution or damage.

g. All containers and tools that contain the product between properly labeled are indicating the processing stage. Before the label was pasted, all previous tagging was removed.

h. All products between and space are labeled correctly, quarantined to the Mutu Surveillance section.

i. All supervision during the process required is accurately recorded at the time of implementation.

j. The actual results of each batch processing stage are recorded and examined as well as compared to the theoretical results.

k. In all stages major attention processing is focused on the possibility of cross-contamination.

l. The deadline and product storage conditions in the process are set.

m. For a critical computerization system prepared for the replacement system for failure.

10.Materials and Kering Products

a. To address the problem of dust control and cross-contamination that occurs during the handling of materials and dry products, special attention is provided on the design, maintenance, as well as the use of means and equipment. If appropriate, use a closed-making system or any other method that is appropriate.

www.peraturan.go.id

2014, No. 79443

b. An effective air-sucking system is installed with a sinkhole in such a way as to prevent contamination from other products or processes. An effective air filtration system or other suitable system is installed to filter the dust. The use of dust-sucking tools in tablet-making and capsule is highly recommended.

c. Special attention is given to protect products against the pollution of metal flakes or glasses. The use of glass equipment is likely to be avoided. Attempted, punch, and die are checked against the keaness or damage before and after use and maintained that a tablet or capsule is either tucked away or left undetected in the machine, a counter-calculating device or a container of ruahan products.

11.Pencampuran and Granulation

a. Mixing machines, peacocks, and mixer are equipped with a dust control system, except for the closed system.

b. Critical operational parameters (e.g. time, speed, and temperature) for each mixing, complaint, and drying process are listed in the parent production document and monitored during the process took place as well as recorded in the batchnote.

c. The filter bag installed on the fluid bed dryer engine should not be used for different products without first washing. For high-risk products or ones that can give rise to the sensititation used a special filter bag for each product. The air that goes into the dryer is filtered and is conducted by the security measures to prevent cross-contamination from the dryer from the dryer.

d. The manufacture and use of a solution or suspension is implemented in such a way that the risk of a microbial contamination or growth can be narrowed.

12.Penprint Tablet

a. The tablet printer is equipped with an effective dust control facility and is placed in such a way as to avoid mixing interproducts. Each engine is placed in a separate room. Unless the machine is used for the same product or equipped with a closed airbending system, it can be placed in a room without a separator.

www.peraturan.go.id

2014, No. 794 44

b. To prevent the mixing needed to be done adequate controls were physically, procedurally and tagging.

c. It is always available an accurate weighted instrument and has been calibrated for the monitoring of the weight of the tablet-processing.

d. Tablets taken from the tablet printer space for testing purposes or other purposes may not be returned to the corresponding batch .

e. The rejected or removed tablet is placed in a clearly marked container about the status and the number is logged in the batch processing note.

f. Each time before it is used, punch and die are checked in to the specifications and compatibility of the specifications. The usage record is saved.

13.Cliquid (Non-Steril)

a. Liquid production is produced as a result of being sheltered from microbial pollution and other pollution. The use of closed systems for production and transfer is highly recommended. The production area where the product or clean container without lid is exposed to the environment is given an effective ventilation with the filtered air.

b. Tanks, containers, pipes and pumps were designed and fitted with a similar form to make it easier to clean and if they needed to be disallowed. The design of the equipment is considered to be as little as possible to have a dead link (dead legs) or a niche in which the residues can accumulate and cause microbial development.

c. The use of equipment from glass is likely to be avoided. High quality stainless steel is the preferred material for parts of the equipment that come into contact with the product.

d. The chemical quality and microbiology of the water used are set and are always monitored. The maintenance of the water system is observed to avoid microbial breeding. Chemically sanitary at the water system followed by welding the procedure has been validated so that the rest of the sanitation materials can be eliminated effectively.

e. Attention is given to the transfer of the material through the pipe to ensure the material is woven to the correct destination.

f. If a pipe network is used to stream an initial material or a ruahan product, it should be noticed for the system

c. Usage ...

www.peraturan.go.id

2014, No. 79445

It is easy to clean. The pipe network was designed and fitted as a demifish, so it was easily dismantled and cleaned.

g. The precision of the measuring system is verified. A measuring stick can only be used for a specific vessel and has been calibrated for a particular vessel for the vessel in question. A measuring stick is made of a material that does not react and does not absorb (e.g., not wood).

h. Attention is given to maintain mixed homogeneity, suspension, and other products during charging. The mixing and filling process is validated. Special attention is given at the start of charging, after termination and at the end of the filling process to ensure the product is always in a homogeneous state.

i. If the product is not directly packaged, the term for the longest time the product will be stored as well as the condition of the storage and the provision is obeyed.

The Gold Ingredient

a. The procurement, handling, and supervision of primary gold materials and other printed gold materials are given the same attention as to the starting material.

b. Special attention is given to the printed material. The printed material is stored with adequate security conditions and non-interested persons are prohibited from entering. Loose labels and other loose print materials are stored and transported in closed containers to avoid mixing. The gilt material is handed over to the person who is entitled to according to the approved written procedure.

c. Each receipt or each batch of the primary gold material is given a specific number or marking indicating its identity.

d. Primary gold, printed gold, or other printed material that is no longer valid or obsolet is destroyed and the concentration is noted.

e. To avoid mixing, only one type of printed gold or printed material is allowed to be placed in the codification at the same time. There is an adequate separator between the codification sites.

www.peraturan.go.id

2014, No. 794 46

15.Activities packaging

a. The packaging activity serves to divide and pack the space products into a product. Packaging is implemented under strict control to preserve the identity, integrity and quality of the final product packaged.

b. There is a written procedure that describes the acceptance and identity of the product of ruahan and gold, the oversight to ensure that the product of the ruahan and the gold in print and not the print and other printed materials are true, supervision-during-packaging process, reconciliation of ruahan products, print gold and other printed materials, as well as examination of the final results of packaging. All packaging activities are carried out according to the instructions provided and using the gold materials listed in the Master packaging procedure. Details of the implementation of the packaging are recorded in the Batch packaging record.

c. Before the packaging activities begin, it is checked to ensure that the workspace and equipment have been clean as well as free from other products, the rest of other products or other documents that are not required for the packaging activities are concerned.

d. All revenues of ruahan products, gold materials, and other printed materials are examined and verified in truth to the Mother packaging procedure or special packaging command.

16.Pre-Codification Material

a. Labels, cartons, and gold materials as well as printed materials that require pre-codification with the batch/lot, expiry date and other information in accordance with the packaging command closely monitored at each stage of the process, since it was received from storage until it becomes part of the product or is annihilated.

b. The gold and other printed materials that are already allocated to the pre-codification are stored in a tightly sealed container and placed in a separate area and guaranteed its safety.

c. The pre-codification process of gold and other printed materials is carried out in a separate area of other packaging activities.

www.peraturan.go.id

2014, No. 79447

d. All of the gold and other printed materials pre-codified are checked before being transferred to the packaging area.

17.Kesiapan Path

Before placing the gold and other printing materials on the packaging, personnel the designated responsible handler of the packaging section immediately performs the path readiness check in accordance with the written procedure approved by the Head of the Mutu Management Section (Warranty of the Mutu), for:

a. ensuring that all pre-packaged materials and products of the previous packaging activities have been properly removed from the packaging line and surrounding area;

b. check the path cleanliness and the surrounding area; and

c. ensure the hygiene of the equipment to be used.

18.The packaging process

a. The risk of error occurred in the packaging can be small in the following way:

1) uses the label in the scroll;

2) the awarding batch on the label's installation path;

3) using the scanner and the electronic label counters;

4) the labels and other printed materials are designed in such a way that each has a special sign for each different product; and

5) the examination visually during the packaging takes place, and It was conducted independently by the Mutu Surveillance section during and at the end the packaging process.

b. Products whose appearance is similar are not packed on adjoining lines unless there is a physical separation.

c. On each name packaging path and the batch batch the packaging of the product can be clearly visible.

d. Containers used for storing bulk products, newly packaged products, or sub-batches are labeled or tagging shows the identity, number, number batch and the product status.

e. The container to be filled is left to the path or place of the packaging in a clean state.

www.peraturan.go.id

2014, No. 794 48

f. All of the packaging personnel obtained the training to understand the supervision requirements during the process and report any deviations found at the time they exercised that responsibility.

g. The packaging area is cleaned regularly and often during work hours and each is a material spill. The hygiene personnel are given training not to do practices that can lead to diffuse or cross-contamination.

h. When a printing press is found at the time of the cleaning is given to the supervisor, the next one is placed in a container reserved for the purpose of reconciliation and then annihilated at the end of the packaging process.

i. The final packaging and half-pack packaging found outside the packaging line is handed over to the supervisor and should not be directly returned to the packaging line. If the product is after being checked by a supervisor it turns out that his identity is the same as batch that is being packaged and the situation is good, then the supervisor can return it to the running of the packaging line. Otherwise, the material was destroyed and the number was noted.

j. Products that have been pre-loaded into the final container but have not been labeled are separated and given tagging to avoid the diffuse mix.

k. A piece of gold equipment that doesn't normally come into contact with the product of space but can be a place of buildup of dust, debris, gold, or products that can then fall into products or polluters or can be causation. The mix of products is being packaged, carefully cleaned.

l. Taken action to control the spread of dust during the packaging process, in particular the dry products. A separate packaging area is required for certain products e.g. low-dosed fish drugs and high risk or toxic products and materials that can incur sensitisation. Pressurized air should not be used to clean up equipment in the areas of packaging activities where cross-contamination occurs.

m. The use of the brush is limited because it can incur the risk of contamination from brush and/or particle brisches attached to the brush.

www.peraturan.go.id

2014, No. 79449

n. Personnel are reminded not to put the ingredients of gold or the product in their pocket. The material is carried by hand or in a closed container and is given a clear sign.

o. The materials required in the packaging process such as lubricant, adhesives, ink, cleaning fluid, and so on, stored in a clear container appear to be different from the container used for product packaging and given clear tagging and conspicuous in accordance with its contents.

19.Completion of the packaging Activity

a. At the completion of the packaging activities, the final packaging is carefully examined to ensure that the packaging of the product is fully in compliance with the Mother packaging procedure.

b. Only products that come from one batch of one packaging activities only can be placed on a single palette. If a carton is not full then the number of packaging is written on the carton.

c. After the process of packaging the packaging, the excess of the gold and the ruahan products to be removed are strictly monitored so that only the ingredients and products are declared to be eligible that can be returned to the warehouse to be used again. The material and the product were given a clear tagging.

d. The supervisor oversaw the calculations and extermination of the material of gold and ruahan products that could not be returned to the warehouse. All the remaining gold items were given tagging but were not used to be counted and destroyed. The number of extermination is recorded in the batch packaging record.

e. The supervisor must calculate and record the number of uses of neto all of the gold and ruahan products.

f. Any unexplained deviation of results or any failure to meet the specifications investigated conscientiously by considering batch of one other product that may also be affected.

g. Once the reconciliation is approved, the product becomes placed in the quarantine area of the product so pending the approval of the Head of the Mutu Management Section (Mutu).\=

www.peraturan.go.id

2014, No. 794 50

20.Oversight During Process

a. To ensure uniformity of batch and fish drug integrity, a written procedure that explains sampling, testing, or checking to be performed during the process of each batch of the product is carried out according to the method has been approved by the Head of the Mutu Management Section (Warranty of the Mutu) and the results are noted. Such oversight is intended to monitor the results and validate the performance of the production process that may be the cause of the product characteristic variation during the running process.

b. The written procedure for surveillance during the process is adhered to. The procedure describes the sampling point, sampling frequency, sample number taken, the specifications to be checked, and the reception limit for each specification.

c. In addition, supervision during the process includes, but is not limited to the following common procedures:

1) all product parameters, volumes, or quantity of product contents are checked at the beginning and during processing or packaging process; and

2) The final packaging is checked during the packaging process with an orderly time lapse to ensure its compliance with the specifications and ensuring all components are in accordance with the specified in the Master's packaging procedure.

d. During the batch processing and packaging process it is sampled at the beginning, middle, and end of the process by the designated personnel.

c. Recovery of all or part of the previous batch , which meets quality requirements, by means of incorporation into another batch of the same product at a fish drug-making stage, authorized in advance. This recovery is performed according to the procedure that has been established after evaluation of the possible risks, including the possible effect of product edar. The recovery is noted.

d. The head of the Quality Management (Quality Assurance) section considers the need for additional testing for a product reprocessing product, or batch that gets the restored product.

e. Batch containing pulihan products should only be graduated after all batch of the pulihan product in question has been assessed and expressed to meet the specified specifications.

f. The products were returned from the circulation and have been removed from the supervision of the makers of the annihilated makers. Such products may be sold again, rebranded, or restored to the batch following only when no doubt the match is still satisfactory after a critical evaluation by the Chief of the Mutu Management Section (Mutu Warranty) as per procedure Written. Such evaluations include consideration of product properties, specific storage conditions required, the condition and history of the product as well as the length of the product in circulation. When there is doubt about the quality, the product should not be distributed or used again, although it is chemically reprocessing to regain the active ingredient possible.

22.Karantina and the Product Surrender Thus

a. The product quarantine is the final stage of control before the submission to the warehouse and ready to be distributed.

www.peraturan.go.id

2014, No. 794 52

Before being passed to the warehouse, tight surveillance was implemented to ensure the product and packaging records batch met all the specified specifications.

b. The written procedure lists the means of submission of the product into a quarantine area, a way of storage while waiting for the graduations, the requirements required to obtain the graduation, and the subsequent transfer to the product warehouse.

c. During the temporary wait of the Mutu Management section, all of the packed batch/lot is held in quarantine status.

d. Except for the sample for quality supervision, there should be no products taken from a batch/lot during which the product is still held in the quarantine area.

e. The quarantine area is a restricted area only for personnel that are absolutely necessary to work or be authorized to enter the area.

f. Products so that require special deviation conditions are given a clear tagging that states the required storage conditions, and the product is stored in the quarantine area with the corresponding conditions.

g. The final embrace of the product is preceded by a satisfactory completion of at least the following;

1) the product meets the quality requirements in all processing and packaging specifications;

2) the sample is left out of the packaging that is marketed in an adequate amount for future testing;

3) packaging and tagging meets all requirements according to the examination results by the quality control section;

4) the reconciliation of printed gold and printed materials acceptable; and

5) the products so that are received in the quarantine area as the number of It's on the delivery document.

h. After an embrace of a batch/lot by the Mutu Management section (Mutu Warranty), the product is moved from the quarantine area to the product warehouse so.

i. At the time of receiving the product so, the warehouse personnel must record the entry of the batch into the stock card in question.

www.peraturan.go.id

2014, No. 79453

23.3 For The Fish Drug Delivery Control

a. The distribution system was designed in such a way as to ensure that the first entry was distributed first.

b. The distribution system produces notes in such a way that the distribution of each batch/lot of a fish drug can be immediately known to streamline the investigation or recall if necessary.

c. The written procedure on the distribution of fish drugs is made and adhered to.

d. Deviations against the concept of first in first out (FIFO) or first forward first out (FEFO) are only allowed for short periods of time and only for responsible leadership approval.

24,Storage Initial Materials, Gold, Product Between, Ruahan Products and Product So

a. Initial Materials Storage and Gold Materials

1) physical separation or other means of validation (e.g. electronic means) are provided for the storage of rejected materials or products, expired, withdrawn from circulatory or fish drugs or Change material. The materials or products, and the storage area are given the right identity.

2) all the starting materials and the gold materials handed over to the storage area are examined the identity truth, container conditions and punctuation marks by the Oversight section Quality.

3) if the identity or condition of the container's initial material or material is in doubt or not according to the terms of the identity or condition, the container is sent to the quarantine area. Furthermore, the Mutu Supervision determined the status of the material.

4) the initial material and the dejected gold were not stored together with the material that was already passed, but in a special area reserved for the rejected material.

5) printed material is stored in "restricted storage area" (restricted storage area) and submission under strict supervision.

www.peraturan.go.id

2014, No. 794 54

6) the oldest stock of early materials and gold and which has the near-date kakadaexpiry date is first used (FIFO principles and FEFO principles).

7) the initial material and the material being retested against identity, strength, quality and purity, as needed, for example after prolonged storage, or exposure to air, heat, or other conditions that may have an adverse effect on the quality of the quality.

b. Product Storage Between, Ruahan Products and Product So

1) products between, ruahan products, and products are quarantined during waiting for quality assurance activity and status determination.

2) each receipt is checked to ensure that the material is be accepted in accordance with the acceptance document.

3) each container of the product between, the product of the space, and the product being handed over to the storage area is checked the suitability of the identity and container conditions.

4) if the identity or condition of the product container between, the product of the space, and the product becomes doubtful or unsuitable to the identity requirements Or her condition, the container was sent to the quarantine area. The quality of quality control determines the status of the product.

c. All materials and products are stored neatly and regularly to prevent the risk of diffuse or pollution and streamline checks and maintenance.

d. Materials and products are not put directly on the floor and between materials and products are laid at a sufficient distance.

e. Materials or products are stored with appropriate environmental conditions. Storage that requires special conditions is provided.

f. The storage conditions of fish drugs and materials according to those indicated on the tagging are based on the stability test results.

g. Temperature monitoring data is available for evaluation. The tools used for monitoring are checked at the specified time lapse and the examination results are logged and stored. All monitoring records are stored for the most timeless term as the age of the material or the products in question plus 1 year, or in accordance with government regulations. Temperature mapping can show temperature as per the specification limit in all areas of storage facilities. It is recommended that the temperature monitoring tool be placed in the area most often showing temperature fluctuations.

www.peraturan.go.id

2014, No. 79455

h. Outdoor storage is allowed for materials packaged in an impermeable container (e.g. metal drums) and their fates are not affected by temperature or other conditions.

i. The activities are split apart from other activities.

j. Each batch of the initial ingredients, the gold, the intermediate products, the ruahan products, and the products that are stored in the warehouse area have a stock card. The stock card is periodically reconciled and when the difference is found and is given a reason when the number approved for use differs from the number at the time of acceptance or delivery. It is documented with a written explanation.

25. Delivery and Transport

a. Ingredients and fish drugs are transported in such a way that it does not damage its integrity and its storage conditions are awake.

b. Special attention is given when using dry ice in a series of cooling systems. In addition, security measures ensure that the material or product does not contact directly with the dry ice, as it can have a bad impact on the quality of the product, for example freezing.

c. When it is necessary, it is recommended that the use of the tool to monitor the conditions, e.g. temperature, during transport. The results of the monitoring were noted for the study.

d. Delivery and transport of materials or fish drugs is carried out only after there is a delivery order. The receipt of the delivery order and the transport of the material is documented.

e. Delivery procedures are made and documented, by considering the nature of the ingredients and fish drugs to be sent as well as special precautions that may be required.

f. The outer container that will be sent provides sufficient protection to the entire external influence as well as a clear and indelible label.

g. Shipping logs are stored, which specify a minimum:

1) delivery date;

2) customer name and address;

www.peraturan.go.id

2014, No. 794 56

3) descriptions of products, e.g. name, form and strength of the supply (if necessary), number batch and amount; and

4) the storage and storage conditions.

h. All records are easily accessible and available when requested.

G. Quality Surveillance

1. The principle

Mutu supervision is an essential part of the CPOIB to provide the certainty that the product consistently has the appropriate quality of purpose in its use. The engagement and commitment of all interested parties at all stages is a must to achieve quality objectives ranging from the beginning of the making up to the distribution of the products so. Quality oversight is not limited to laboratory activities, but it must also be involved in all decisions related to the quality of the product. The undependence of quality surveillance from production is considered a fundamental thing to allow quality supervision to perform satisfactory activities.

2. General

In accordance with organizational structure, quality supervision has the main functions related to sampling, specifications, testing, and disintegration procedures to ensure that testing is performed against materials and products which is generated to meet the quality of the requirements.

The Mutu supervision has other functions, among others setting, validating and implementing all quality supervision procedures, evaluating, maintaining and storing the default, ensuring the truth label the container of materials and products, ensuring that the stability of the active substances and End products are monitored, participate in investigative complaints related to product quality, and take part in the waste monitoring.

Each fish drug manufacturer has an independent quality supervision function of the other part. It is the availability of competent personnel to ensure that all quality control functions can be implemented effectively. Quality supervision personnel should be required to have access to the production area for sampling and investigation.

www.peraturan.go.id

2014, No. 79457

a. Every producer of the fish drug must have a piece of Mutu's supervision. This section must be independent of the other part and under the responsibility and authority of a person with appropriate qualifications and experience, which carries one or more laboratories. This section is equipped with a means to ensure that all quality supervision activities are performed effectively and reliably.

b. Quality supervision includes all analytical activities performed in the laboratory, including sample retrieval, preliminary materials inspection and testing, intermediate products, ruahan products, and so. These include also the test of stability, environmental monitoring programs, testing conducted in the framework of validation, the handling of the sample of the dead, compiling and updating the specifications of the materials and products and methods of the test.

c. The Quality Supervision section applies to the rate procedure to guarantee the quality of the initial materials before it is used for the production and final product quality prior to distribution.

d. The following quality assurance basic requirements include:

1) adequate means and infrastructure, trained personnel, sample retrieval standards, preliminary materials testing and testing, gold-based materials, products between, ruahan products and products So, as well as waste monitoring;

2) sampling of initial materials, gold, intermediate products, ruahan products and products so, as well as waste monitoring performed by personnel according to methods by standard methods and procedures approved by Quality Supervisor;

3) testing is prepared and validated;

4) is made a note either manually and/or with a recording device, so that shows all sample needs, surveillance and testing procedures are properly performed and any deviation is recorded and investigated;

5) The results of the examination results are made manual on analysis of the initial materials, the gold, the product between, the ruahan product, and the product so are formally assessed and compared to the specifications;

6) the product thus contains an active substance with a qualitatively and quantitative composition as agreed upon at the time of registration, with the degree of purity that required as well as packaged in a suitable container and labeled the correct;

www.peraturan.go.id

2014, No. 794 58

7) samples of the stay from the initial materials and end products are stored in sufficient quantities to be retested when necessary. The final product sample is stored in the number of final packaging except for the large packaging; and

8) is made a record of the surveillance and test results against the initial materials, the intermediate product, the ruahan product and the final product are formally assessed and compared to against the specifications, including the monitoring and evaluation of related production documentation and assessment of deviations from the specified procedure.

All such activities are carried out according to the written procedure.

e. Quality Surveillance has the following subject:

1) compiling and revising the supervising procedures and specifications;

2) preparing detailed written procedures for conducting all checks, testing and analysis;

3) compiles a program and sample retrieval procedure in writing;

4) ensures the correct labeling of the container of materials and products;

5) stores the death sample for future referrals;

6) passed or reject each batch of initial materials, intermediate products, ruahan products, or products so;

7) performs the evaluation of the stability of all the products so sustainably and the initial materials if needed, as well as establish the storage conditions of materials and products based on its stability data;

8) set the initial materials save and product So, based on the stability data and its retention conditions;

9) play a role or assist the execution of the validation program;

10) preparing a secondary benchmarking match in the applicable test procedure and saving the default it was in the right condition;

www.peraturan.go.id

2014, No. 79459

11) keeps the analytical record of the test results of all the samples taken;

12) conduct the product evaluation so change and establish whether the product may be passed or reprocessed or should destroyed;

13) took part in a self-inspection program along with other parts of the company;

14) provided a recommendation for the creation of a fish drug-making activity after conducting an evaluation of the contract recipients ' ability concerned to create a product that meets the specified quality requirements company; and

15) the quality supervision personnel have access to the production area for sampling of the required enquiries.

3. How To Be A Good Quality Surveillance Lab

a. Building and Facilities

1) The test laboratory is designed, equipped with equipment, and has adequate space so that it can carry out all related activities.

2) Provided a suitable and safe means for waste. Dumped. The toxic materials and flammable materials must be stored in a closed and separate closet with appropriate design.

3) The Laboratory of the henes is physically separate from the production space.

4) The biological laboratory, microbiology, and chemistry separate one from another.

5) A separate room for the instrument may be required to provide protection against electrical interference, vibration, excessive humidity as well as other external influences or if necessary for isolats the instrument.

6) The laboratory design is considering the suitability of construction materials, the protection of personnel against smoke and ventilation. Separate air handling units are required for biological and microbiology laboratories.

7) All pipes and equipment are given adequate tagging and are given special attention to connectors or adapters

2) Provided ...

www.peraturan.go.id

2014, No. 794 60

that cannot be exchanged for gas and harmful liquids.

b. Personnel

1) Each personnel who is in charge of supervision or conducting laboratory activities has an education, gets the training, and the appropriate experience or combination to enable the execution of the task properly. The duties and responsibilities of each personnel are detailed in the description of the task or in other suitable forms.

2) Each personnel wear protective clothing and security tools such as respirators or masks, protective glasses and mittens. Acid or base-hand hand according to the task is performed.

c. Equipment

1) Appliances and laboratory instruments in accordance with the testing procedures performed.

2) The procedure remains for the operation of each instrument and equipment is available and placed near the instrument or equipment that concerned.

3) Appliances, instruments, and related software are qualified /validated, cared for, and calibrated within the specified time lapse and the documentation is stored. Examination to ensure that the instrument is functioning either on a daily or before the instrument is used for analytical testing.

4) The calibration date, treatment, and recalibration according to the schedule is clear on equipment or by other means appropriate.

5) The damaged device or in the care is given a clear tagging. The damaged device was not used before it was fixed.

6) The safety water and eye washing pans were available near the lab work area.

d. Reagents and Media Cultures

1) The acceptance or manufacture of reagents and cultural media should be noted.

www.peraturan.go.id

2014, No. 79461

2) The culture and media of the culture created in the laboratory follow the written making procedures and are labeled as appropriate. On the label are listed concentrations, standardisation factors, usage time limits, re-standardization dates, and storage conditions. The label was signed and written on the date by the officer who made the reagent.

3) Both positive and negative control controls were used to ensure the suitability of cultural media. The concentration of inoculum in positive control is adjusted to the sensitivity of desired growth.

e. Default Default/Default Default

1) Default is to be the responsibility of designated personnel.

2) The comparison Baku is used as described in the monograph in question.

3) The default of the match A secondary or a work comparison default can be created and used after appropriate testing and periodic examination to correct the storage that occurred and ensure the accuracy of the results.

4) All the standard of sparring is stored and Handled appropriately.

5) On the default label The match is added, the date of creation, the expiration date, the first date of the container is opened and if it needs to be saved.

f. Test specifications and Procedures

1) validated test procedures with regard to the facilities and equipment that existed before the procedure is used in testing.

2) All testing activities are performed according to the method which have been approved at the time of the issuer of the fish drug registration number.

3) The specifications and testing procedures for each initial material, the product between, the product of the space, and the product so include specifications and testing procedures regarding identity, purity, quality and level/potential.

4) The test procedure includes:

www.peraturan.go.id

2014, No. 794 62

a) the number of samples required for testing and which should be stored for future referrals;

b) the amount of each reagent, a buffer solution, and so on to the test;

c) the formula the calculations used; and

d) the expected value and the tolerance limit of each test.

5) The test procedure includes a retesting frequency of each of the initial materials determined by considering its stability.

6) All test activities follow the instructions listed in the testing procedure for each ingredient or product. The results of the test, especially those that concern the calculation, are examined by the supervisor before the materials or products are passed or rejected.

7) The test materials are fish and/or other animals that will be used for product testing so:

a) if any of the sick should be treated;

b) is quarantined and/or adapted;

c) is maintained and observed to ensure the suitability of its use;

d) must be identified; and

e) all data is recorded and stored to be able to show the history of its use.

g. Analysis Note

The analysis note includes:

1) the name and the number batch of the sample and the form of supplies;

2) the name of the officer who took the sample;

3) the analytical method used;

4) all data, such as weight, created buret, volume, and dilution reading;

5) calculations in the unit size and formula used;

6) a statement regarding the limit of tolerance;

7) a statement whether it meets or does not meet the specification;

8) the date and the signature of the officer who did the testing and the officer who checked calculation;

www.peraturan.go.id

2014, No. 79463

9) the statement was passed or rejected and the extermination proposal, signed and dated by the authorized officer;

10) the name of the supplier, the overall number, and the number of container materials received; and

11) the overall number and number of initial material vessels, gold, intermediate products, ruahan products, products so of every batch analyzed.

h. Sample retrieval handling

1) The sampling was performed for each batch of the initial materials, the gold, the ruahan product, and the product so. The validity of the overall conclusion cannot be based on the tests performed against a sample that does not represent a single batch. Therefore the correct sampling method is an important part of the quality assurance system.

2) The sampling is done in such a way as to prevent contamination and other effects that affect the quality of the quality. The sampled container is labeled as containing the container's contents, the batch number, the sampling date, and the sign that the sample was taken from the container. The container is closed back after sampling.

3) The personnel who took the sample obtained initial training and continued training on the correct method of sampling. The training includes:

a) sampling pattern;

b) sampling written procedures;

c) engineering and equipment to take samples;

d) cross-contamination risk;

e) the necessary precautions. taken against unstable and/or sterile materials;

f) the importance of paying attention to the description of materials, containers and labels visually; and

g) the importance of noting the unexpected or unusual.

4) All the takers The sample and the sample container are made of an inert material and maintained its cleanness.

www.peraturan.go.id

2014, No. 794 64

5) The sampling instructions included:

a) sample retrieval methods and techniques;

b) the equipment used;

c) the number of samples taken;

d) the sample share instructions were appropriate. needs;

e) the type of sample container that must be used, i.e. whether for an aseptic or normal sampling;

f) the identity of the container taken by its sample;

g) The special warning should be taken especially for relating to sampling of sterile or hazardous materials;

h) storage conditions; and

i) instructions on how to purge and store sample taker tools.

6) Each sample container is labeled indicating:

a) sample material name;

b) the batch number or lot;

c) the container number taken the sample;

d) the signature of the officer who took the sample; and

e) the sampling date.

7) Prior to and after each use, the sample taker was cleared, if needed to be sterilized, and stored separate from other laboratory tools.

8) At the time of sampling is conducted prevention in order to There was no pollution or mix-up against or by the material that was taken by the samples. All the sample-taking devices that come into contact with the clean ingredients. Special attention may be required for the handling of hazardous or potentially high materials.

9) Perstay sample:

a) The sample is left with a complete identity that represents each batch of the initial material for each Acceptance is stored for a specified period of time.

b) The sample of the death with a complete identity which represents each batch of products so that the complete packaging form is stored for a given period of time. A product sample is stored in the same condition as a marketing condition as shown on the label.

www.peraturan.go.id

2014, No. 79465

c) The number of sample samples is at least twice the number of samples needed for complete testing, except for the sterility test.

d) The death sample represents each batch or product taken The sample. Other samples can also be taken to monitor the most critical part of the process (e.g. the beginning or end of the process).

e) The death sample of each batch of the product becomes stored up to one year after the expiry date. The product becomes stored in its final packaging and in a set condition. Initial material samples (other than solvents, gases, and water) are stored for a minimum of two years after the redeability of the product becomes related, if the stability is possible. The term of storage can be reduced if the stability is shorter than the one listed in the specification.

i. Initial Material Handling

1) The identity of a batch of initial materials is usually only certain if the sample is taken from each container and performed an identity test against each sample. Sampling may be made from a portion of the container when it has been made a validation procedure to ensure that not a single initial material container is mislabeled its identity.

2) Mutu a batch of the initial material can be assessed with take and test the representative samples. Samples taken for the identity test can be used for such purposes. The amount taken to prepare a representative sample is determined statistically and is pronounced in a sampling pattern. The number of samples that can be mixed into one composite sample is specified by consideration of the properties of the material, the information about the supplier and the homogeneity of the composite sample.

3) The acceptance date of each material used for testing activities For example, a reagent and a fight shall be set forth in a matter of measure. Usage instructions and storage must be followed. In certain respects the identification and/or other testing of the material for the reagent is accepted or before it is used.

www.peraturan.go.id

2014, No. 794 66

j. Exam and Early Materials Testing, Product Between, Ruahan Products, and Product So

1) Each preliminary material is tested against the fulfillment of the identity specifications, strength, purity, and other quality parameters.

2) Each specification of the initial material, The products between, the product and product are approved, stored by the Mutu Surveillance Section, except for the product so that the Chief Management Officer of the Mutu has to be approved (Mutu Warranty).

3) Revision of any initial materials specification, intermediate products, ruahan products, and products so it is regularly conducted to meet Indonesian Pharmacope (FI) or Indonesian Animal Drug Pharmacope (FOHI) last edition, or another official compendium Minimum equivalent to FI and FOHI.

4) The gilt material meets the specification, with an emphasis on the compatibility of the material to the product it is loaded into. Critical and critical physical defects and tagging truths that can give a dubious impression of the quality of the product examined.

5) The Product Antara and Product Ruahan

a) To ensure uniformity and integrity batch, the supervision during the process is performed during the representative sample testing of each batch of the product between and the ruahan product for identity, strength, purity and its mull. Approval of an absolute Mutu Surveillance Section is required after the critical production phase is completed or if the product is long before the next production stage is implemented.

b) The product between and the rejected ruahan product is given the tagging and controlled with a quarantine system designed to prevent its use in the next process, unless the product is judged to be eligible for later reprocessing.

6) Product so

a) Each batch of the product So a test is done on the last product specifications. Graduated.

b) The product becomes rejected if it does not meet the quality specifications and requirements. Reprocessing can be done if possible, but the product reprocessing product must meet all specifications and

www.peraturan.go.id

2014, No. 79467

quality requirements before being passed for distribution.

k. Handling of the Gold Materials

The least amount of gold sample material sampling procedures attention the amount received, the quality required, the properties of the material (e.g. primary gold and/or printed gold materials), the production method and the Knowledge of the implementation of quality assurance systems in the manufacture of gold-based materials based on audits. The number of samples taken is determined statistically and is mentioned in the sampling pattern.

l. Environmental monitoring

Environmental monitoring is conducted with:

1) water monitoring regularly for processes, including at point of use, against chemical and microbiological quality. The number of samples and testing methods is able to detect an indicator organism in low concentrations, for example Pseudomonas;

2) microbiological monitoring periodically in the production environment;

3) periodic testing of the environment around the production area to detect other products that can contaminate the products being in the process; and

4) air spruce monitoring.

m. Supervision During the Process

All supervision during the process, including those conducted in the production area by production personnel, is conducted according to the method approved by the Mutu Surveillance Section.

n. Retesting the

1) Specified the appropriate storage time limit for each initial ingredient, intermediate product, ruahan product and product. Once the deadline is determined, such materials or products must be retested by the Mutu Surveillance Section on identity, strength, purity, and quality. Based on the results of such a test the material or the product may be resold for use or rejected.

www.peraturan.go.id

2014, No. 794 68

2) When a material is stored on a condition that is not compatible with the specified, the material is retested and is declared passed by the Mutu Surveillance Section before being used in the process.

o. Reprocessing

1) Additional testing of the product so reprocessing is done as per provisions.

2) Further testing of the stability is performed against the product of the reprocessing results as needed.

p. Evaluation of Quality Control of Production Procedure

1) Quality supervision section as well as in the development of the Master Processing Procedure and Master packaging procedure for each size batch of a fish drug to guarantee uniformity from batch to batch created.

2) The Mutu Surveillance Section was instrumental in the development of the production equipment cleaning and sanitation procedures.

q. Stability Testing

1) The stability testing program is designed to assess the stability characteristic of fish drugs and to determine the appropriate storage conditions and expiry dates.

2) The stability testing program includes:

a) the sample number and test interval based on the statistical criteria for each sample examined to ensure the estimation of stability;

b) storage conditions;

c) reliable, meaningful and specific testing methods;

d) product testing in the same packaging form as that is circulated; and

e) product testing for reconstitutions, done before and after reconstitutions.

3 )Testing of stability is done in terms of as follows:

a) the new product (usually done in the batch pilot);

www.peraturan.go.id

2014, No. 79469

b) a new packaging that is different from the specified standard;

c) formula changes, starting processing methods or source/source materials and secondary gold materials;

d) the dilution batch with Exceptions include batches that are different from the standard or reprocessed batch; and

e) outstanding products.

H. Self-Inspection (Internal Audit) and Mutu Audit

1. The principle

The purpose of self-inspection is to evaluate all aspects of production and supervision of the quality of fish drug manufacturers in order to meet the provisions of the CPOIB. The self-inspection program is designed to detect weaknesses in the implementation of the CPOIB and to establish the necessary correcting measures. Self-inspection is done independently and detailed by the competent officers of the company. Self-inspection can use an independent outside auditor. Self-inspection is done routinely. In addition, there is a special situation, for example, in the event of a retraction of a fish drug or a repeat rejection. All suggestions for correcting action to be implemented. Procedures and self-inspection records are documented and made an effective follow-up program.

2. Self Inspection (Internal Audit)

a. Aspect For Self Inspection (Internal Audit)

The inspection check list of self (internal audits) is created by presenting minimum and uniform requirements standards. This list contains questions about the provisions of the CPOIB including among others:

1) personalia;

2) buildings including facilities for personnel;

3) building care and equipment;

4) storage of initial materials, materials gold and fish drugs so;

5) equipment;

6) processing and supervision during process;

7) quality supervision;

www.peraturan.go.id

2014, No. 794 70

8) documentation;

9) sanitation and hygiene;

10) the validation and re-validasi;

11) calibration tool or measurement system;

12) the procedure for the recall of a fish drug so;

13) Complaint handling;

14) surveillance label; and

15) previous self-inspection and remedial actions.

b. Self Inspection Team (Internal Audit)

The management forms the least composed self-inspection team (internal audits) consisting of 3 (three) experienced members in their respective fields and understands the CPOIB (Head of the Mutu Warranty Section, Head of the Security Council). "Quality of Quality and Head of Production". Team members can be formed from within or from outside the company. Each member is independent in conducting an inspection and evaluation.

c. Scope and Self Inspection Frequency

Self inspection can be performed per part according to the needs of the company. Thorough self-inspection is performed at least 1 (one) times a year. The frequency of self-inspection written in the procedure remains an inspection of self.

d. Advanced Self and Self Inspection Report

The report was made after the self-inspection was completed. Reports include:

1) self-inspection results;

2) evaluation and conclusion;

3) correcting action suggestions; and

4) follow-up/correcting actions.

The company management evaluated the inspection report of self and An action plan is not available for the Cloud Service, and is not available for the Cloud Service. Audit and Supplier Agreement

1) Head of the Mutu Management Section (Mutu Warranty) is responsible with other parts related to the approval of reliable suppliers supplying the starting materials and the materials of gold and meeting Pre-defined specifications.

www.peraturan.go.id

2014, No. 79471

2) Created a list of approved suppliers for the starting materials and the material of gold. The supplier list is regularly reviewed.

3) Evaluated before the supplier is approved and put on the supplier list or specifications. Evaluation of considering the supplier history and the nature of the supplied materials.

4) If audits are required, such audits establish the ability of the supplier in the fulfillment of the CPOIB standards.

5) All suppliers are evaluated on a regular basis.

3. Quality audit

Holding quality audits are useful as a complement of self-inspection. Quality audits include the examination and assessment of all or part of the quality management system with specific objectives for improving quality. Quality audits are generally carried out by specialists from outside independent or team formed specifically for this matter by the management of the company. Quality audits may also be extended against suppliers.

I. The Handling Of The Complaint Against The Product, The Recall Of The Product and The Change Product

1. Principle

All complaints and other information relating to the possibility of damage to fish drugs are studied under study according to the written procedure. To deal with all pressing cases, a system is composed, if necessary to cover the recall of known products or suspected defects of the circulation quickly and effectively. A product retraction is a recall process from one or more of the batch or the entire batch of a particular product from the circulation.

The product resumption is performed if the product is found with a quality defect or a product. If there are any reports of serious adverse reactions and risks to health. The withdrawal of products from the circulation may result in delays or termination of the manufacture of the fish. The change is a fish drug that has been circulating, which is then returned to fish drug manufacturers due to complaints about damage, expiry, or other reasons, such as container conditions or packaging, which may lead to doubt. identity, quality, amount and security of the fish drug are concerned.

www.peraturan.go.id

2014, No. 794 72

2. Complaint

a. Designated personnel who are responsible for handling complaints and deciding actions to be performed with sufficient personnel to assist them. If such personnel are not Head of the Mutu Management Section (Warranty of the Mutu), then the concerned must understand the handling of the entire complaint, inquiry or retraction of the product.

b. Reports and complaints about the product may be caused by:

1) physical, chemical, or biological damage of its products or packaging;

2) expiry or other reason, such as the condition of the container or packaging that may incur any doubt. identity and quality;

3) adverse reactions such as toxicity or other reactions; and/or

4) product therapeutic effects, such as non-efficacy products or low clinical responses.

c. The written procedure must be made available by detailing the investigation, evaluation, corresponding follow-up, including consideration for the recall of the product, in the face of complaints against suspected fish drugs. Each report and complaint is investigated and evaluated thoroughly and in depth that includes:

1) the study of all information regarding reports or complaints;

2) the inspection or testing of a fish drug sample is eluted and received And if there are required testing of the Cloud Service, Client may not use the Cloud Service for any other purpose, including but not limited to, the amount of data that is used to the Cloud Service.

d. The handling of a complaint and a report of a product including the evaluation results of the investigation as well as the follow-up are filed and reported to the management or the related sections.

e. Special attention was given to establish whether the complaint was caused by forgery.

Any complaint concerning the damage to the product is recorded which includes details regarding the origins of the complaint and investigated thoroughly and deeply. Header

www.peraturan.go.id

2014, No. 79473

Mutu supervision is involved in the study of the problem.

f. If the product on a batch is found or suspected to be defective, it is considered to check the other batch to ensure if the batch another is also affected. Special batch which contains reprocessing results of the disabled batch investigated.

g. After conducting an investigation and evaluation of reports and complaints about a product is conducted. This follow-up includes:

1) correcting actions when required;

2) withdrawates a batch or the entire end product in question; and

3) the other actions are appropriate.

h. Logs of the complaint are regularly studied to identify specific things or recurring problems, which require attention and the possibility of retraction of the product from circulation.

i. The Drug Surveillance Authority is notified when a fish drug manufacturer is considering actions related to the possibility of creating errors, product damage, forgery or anything else serious about the quality of the product.

3. Product Retraction

a. Personnel responsible are appointed to perform and coordinate the recall of the product and supported by the sufficient staff to handle all aspects of the recall in accordance with the extent of the urgency. The personnel are independent of the sales and marketing sections. If these personnel are not the Chief Management Officer of Mutu (Warranty of the Mutu), then the concerned understanding of any operating withdrawal is returned.

b. A written procedure is available, which is checked periodically and updated if necessary, to set any retraction action.

c. Product recall:

1) may be initiated by a fish drug manufacturer or at the behits of the Director General;

2) internally comes from the Chief of Mutu Management (Mutu Warranty) and company management;

www.peraturan.go.id

2014, No. 794 74

3) may involve one batch or more or all batches of final products; and

4) may result in delays or termination of product creation.

d. Implementation of Retraction:

1) The product recall action is done as soon as it is known to have a quality defective product or received a report on adverse reactions;

2) the use of high-risk products against health stopped and resumed with immediate recall;

3) recall reaching up to the consumer level;

4) The product recall documentation system in fish drug manufacturers is implemented rapidly, effective and the tuntas; and

5) the guidelines and procedures of recall against the product created and performed quickly and effectively from the entire distribution chain ' s eyes.

e. The Fish Drug Surveillance Authority of the importing country is informed immediately if it will be made a recall due to a defect or a suspected defect.

f. Distribution records are used by personnel responsible for the recall. The distribution record contains the complete information about the distributor and the customer supplied directly (with the address, phone number, and/or fax/e-mail numbers at work hours and outside the working hours, the number batch and the amount sent), including overseas distributors for products in export and medical samples.

g. The retracted product is identified and stored separately in a secure area while awaiting a decision on the product.

h. The development of the recall process was recorded and made the final report, including the reconsialization result between the number of products sent and the rediscovered.

i. The effectiveness of the staging of the recall is evaluated over time.

4. Return Product

a. Fish drug manufacturers prepare procedures for detention, investigation, and test of change products as well as

www.peraturan.go.id

2014, No. 79475

decision making whether the change product can be reprocessed or should be destroyed after a critical evaluation is done. Based on the results of the evaluation, the change product can be categorised as follows:

1) a return product that still meets the specification and is therefore able to be returned to the inventory;

2) the reprocessed product (s); and

3) return products that do not meet the specifications and cannot be reprocessed.

b. Procedures for the detention, investigation, and product testing of the change include:

1) identification and quality records of change products;

2) change of product storage in quarantine;

3) inquiry, testing, and analysis Product development by a quality control section;

4) a critical evaluation before management takes the decision on whether the product can be reprocessed or not; and

5) additional testing of the requirements of the reprocessing product.

c. Unreprocessed change products must be destroyed. The extermination procedure of the material or destruction of the rejected product must be prepared. This procedure includes preventive measures against environmental pollution and misuse of materials or products by persons who have no authority.

J. Documentation

1. The principle

Documentation is part of the information system of the menajemen and is an essential part of quality assurance. A clear documentation is a fundamental thing to ensure that each personnel receives a clear and detailed description of the task so that it is less likely to be mistaken for a misinterpretation and a fallaness that usually arises because it only relies on it. Verbal communication. Specification of the master production document/formula creation, procedure, method, and report instructions and notes must be free of error and available in writing. The document must be read clearly.

www.peraturan.go.id

2014, No. 794 76

2. Generic

a. Decipher the requirements that must be filled with products or materials used or obtained during the creation. This document is the basis for evaluating the quality. Master production documents, master processing procedures, and master packaging procedures (manufacturing formulate, processing instructions and packaging instructions) specify all the initial materials and materials of the gold being used as well as outlining all processing operations. And the packaging. Procedures contain ways to perform certain operations, e.g. cleaning, dressing, environmental control, sampling, testing, and operation of equipment. The record presents a history of each batch of the product, including its distribution and all relevant circumstances that are influential in the end product quality.

b. The documents are designed, prepared, studied, and carefully distributed. The creation and registration document section (dossier) is relevant accordingly.

c. The document is approved, signed, and dated by the appropriate personnel and authorized, as well as authorized.

d. The contents of the document do not mean double, title, nature and its purpose are declared clearly. The appearance of the document was made neat and easy to check. The documents of the reproductive results are clear and read. The reproduction of the work document of the parent document may not cause errors caused by the reproductive process.

e. Documents are regularly reviewed and maintained to always up-to-date. If a document is revised, a system execues a system to prevent the use of a document that is not intentionally applicable.

f. The document is not hand-written, but if the document requires a data record, then this record is clearly written, read, and cannot be removed. Provided enough space to record the data.

g. All changes made to the logging on the document are signed and given a date, the change allows the reading of the original information. If required, the reason for the change is noted. Records are made or equipped in every step that is performed and such that all significant activity on the manufacture of fish drugs can be traced. The making records are stored for at least one year after the product expiry date so.

www.peraturan.go.id

2014, No. 79477

h. The data can be recorded using an electronic data processing system, a photographic way, or other reliable way, but detailed procedures are related to the system used available, and the accuracy of the records is checked. Where documentation is managed using electronic data processing methods, only personnel authorized may be able to use or modify data in the computer, and the changes and deletion are noted. Access is limited by using the password (password) or in other ways, and the entry results of critical data are checked independently. The electronically stored "batch records" are protected with supporting transfers (back-up transfers) using magnetic tape, microfilm, paper, or other means. Data is always available during the storage period.

3. Documentation Required

a. Quality management documentation

The written document must exist for the quality management system that manages the quality of quality management and the quality restudy of the product.

b. Personnel documentation

The written procedure document must exist for the personnel set up about the organization and the responsibilities of core personnel, employee recruitment, employee supervision and training. Records must be made for employee, surveillance, and employee training.

The training execution record includes:

1) the training date;

2) the name of the employee following the training;

3) the instructor's name, part or agencies that provide the training;

4) the training materials and aids used;

5) the reenacings are performed, if any; and

6) an evaluation of the trainees

c. Building documentation and facilities

The procedure documents and written records must exist for maintenance, cleaning and repair of the room or building and facilities. Logging must be done with

www.peraturan.go.id

2014, No. 794 78

either for the implementation of maintenance, cleaning and repair of the room or building and facilities.

d. Appliance documentation

1) Maintenance and Repair

The written procedure must be available for the means of use, maintenance and repair of instruments and equipment that includes the personnel authorized to compile the program, the name of the Appliance and the instrument, including contacting a competent outside party for such activities. Record maintenance, maintenance and repair of equipment and instruments are kept well.

2) Kalicalibration

Written procedures must be available for instrument calibration and equipment maintenance that includes personnel authorized Compiling programs, calibrated tool names, instruments and equipment maintenance, contact the outside competent authorities for calibration and appliance treatment. The calibration and calibration certificate is stored well.

3) Device Work Instructions

Available clear operating written procedure for the main equipment of manufacture and testing.

4) Log book

Provided logbook to record primary or critical equipment, as necessary, all validation, calibration, maintenance, cleaning and repair activities, including date, identity of personnel who are labeling such activities. At logbook is also noted in chronological order the use of primary or critical equipment and the area where the product is processed.

e. Sanitation and Hygiene documentation

1) Environmental Monitoring Procedures

Written procedures should be available for environmental monitoring that includes personnel authorized to take environmental samples (waste), methods and tools that must be used, the number of samples to be taken and the date of retrieval, any security measures that must be noticed to prevent the contamination of the sample. The tests were executed.

www.peraturan.go.id

2014, No. 79479

If environment monitoring is associated with the outside then it must be accompanied by a co-statement of cooperation.

2) Notes

The record must be available for environmental monitoring that includes the personnel given Authorization to take the environmental sample, the device that must be used, the sample number must be taken and the date of retrieval, any security measures that must be advised to prevent the contamination of the sample. The tests were executed. While monitoring the environment concerns the outside, it must be called a co-statement of cooperation.

f. Production Documentation

1) Specifications

a) Initial Material Specification

Documentation of the initial materials specification includes:

(1) materials description, including:

(a) specified name and reference code (code internal) internal;

(b) reference to the pharmacopoeic monograph, if any;

(c) approved suppliers and if possible, the manufacturer of materials; and

(d) the microbiological standard, if any.

(2) the sampling instructions and the testing or referral procedure;

(3) qualitative and quantitative requirements with acceptance limit;

(4) storage conditions and security measures; and

(5) the storage time limit before retesting.

b) Documentation Specification Specification

Documentation of the gold-based material includes:

(1) the description of the material, including:

(a) specified name and internal reference code (product code);

(b) the pharmacograph monograph reference, if any;

www.peraturan.go.id

2014, No. 794 80

(c) approved suppliers and, if possible, materials manufacturer;

(d) microbiological standards, if any.

(2) sample sampling and referral testing or procedure;

(3) the requirements of the qualitative and quantitative easing with acceptance limits;

(4) storage conditions and security measures; and

(5) limits of storage time before re-testing.

c) Documentation of the Product Between and the Ruahan Product

The product specifications of between and the space products are available, if the product is purchased or sent, or if the data from the intermediate product is used to evaluate the product. Specifications are similar to the initial materials specifications or products so, as necessary.

d) Documentation of the Product Specification So

Documentation of the product specifications so includes:

(1) the name of the specified product and the reference code (code product);

(2) formu/composition or referrals;

(3) description of the form of supplies and descriptions of packaging, including packaging size;

(4) sample sampling and referral testing or procedure;

(5) requirements qualitative and quantitative and acceptance limits;

(6) storage conditions and actions special handler, when required; and

(7) edar/save time.

2) Parent Production Documentation

Formally Authorized Master Production Documentation includes name, supply form, strength and description

www.peraturan.go.id

2014, No. 79481

products, compilers and parts, checker names and document distribution lists and contain the following:

a) the parent production documentation containing the production formula of a product in the form Certain items and strengths, not depending on the size batch;

b) the information is common that describes the type of primary gold that must be used or alternatively, statements regarding product stability, security measures during storage and other security measures that must be done during processing and product packaging;

c) the composition or product formula for each dose unit and for one batch size sample;

d) a full list of preliminary materials, both of which will not change or that will undergo changes during the process;

e) initial materials specification;

f) a complete list of gold-packing materials;

g) the specification of primary gold material;

h) the processing and packaging procedures;

i) the list of equipment that can be used for processing and packaging;

j) supervision during the processing and packaging process; and

k) the time Edar. Save it.

3) The master processing procedure documentation

A formal authorized master processing procedure documentation must be available for each product and batch size product to be created. The master processing procedure documentation includes:

(a) product name with a product reference code referencing its specifications;

(b) the description of the form, product strength, and batch size;

(c) the list of all the initial materials must be used, by mentioning each of the numbers, expressed by using the name and referent (product code) specific to that material and

www.peraturan.go.id

2014, No. 794 82

listed if any material is lost during the process;

(d) the statement regarding the expected end result with the acceptance limit, and if required, any result between relevant;

(e) the statement regarding the main processing and equipment location to be used;

(f) the method or reference method should be used to prepare critical equipment (e.g. cleaning, assembly, calibration, sterilization);

(g) detailed instructions process stage (e.g. examination of materials, initial treatment, order of addition of materials, Mixing, temperature, temperature);

(h) instructions for all supervision during the process with its acceptance limits;

(i) if necessary, the storage terms of the product line; including container, labeling and special storage conditions; and

(j) all special actions that should be noticed.

4) The Master Pack Procedure Procedure

Documentation of a formally authorized master packaging procedure is available for each product and size batch as well as the size and type of packaging. This document generally includes or refers to the following:

(1) product name;

(2) the description of the form and its strength, if required;

(3) the size of the packaging expressed in the number, weight, or product volume in the the final container;

(4) a complete list of all the gold materials required for a single batch standard, including the number, size and type alongside the code or reference number related to the specifications of each packaging material;

(5) the example or the reproduction of the relevant printed gold material and the specimen that shows the place to print the number batch and the expiry date batch;

(6) special actions to be noticed, including careful checking of the area and equipment for

www.peraturan.go.id

2014, No. 79483

ensuring the path readiness (line clearance) prior to activities began;

(7) descriptions of packaging activities, including any significant additional activities as well as the equipment to be used; and

(8) surveillance during detailed processes including sampling and acceptance limits.

5) Production records Batch

Record production batch, consisting of batch processing records and packaging records batch, which is the production of each parent processing procedure and procedure the parent packaging, and contains all data and information related to the execution of production of a batch product. Sometimes in the production logs of the batch, the procedure indicated in the parent production procedure is no longer listed in detail.

a) The Reprocessed Note Batch

Record processing batch must be available for each batch processed. This document is created based on the relevant section of the applicable master processing procedure. The method of making these records is designed to prevent transcription errors. Note that lists the "batch " numbers that are being created. Before a process begins, the examination is carried out, that the equipment and the workplace have been free from previous products and documents or materials that are not required for the planned processing, as well as clean and appropriate equipment for the The use During processing, the information as follows is recorded at the time each action is performed and after complete records are dated and signed with the consent of the personnel responsible for the processing activities:

(1) the name product;

(2) the date and time of the beginning, of the significant stage between and from the processing completion;

www.peraturan.go.id

2014, No. 794 84

(3) responsible personnel names for each stage of the process;

(4) paraf operators for various significant processing steps and, where necessary, paraf of personnel inspeting each of these activities (e.g. rebalancing);

(5) the number batch and/or the analysis control number and real amount of each initial material weighed or measured (including the number batch and the amount of recovery results or reprocessing results that added);

(6) all relevant processing or events activities and main equipment used;

(7) surveillance records during the process and paraf of personnel performing as well as results obtained;

(8) the number of product results obtained from the processing stage is different and important; and

(9) the record of the Special issues that occur including the description with the authorization signature for any deviation to the parent processing procedure.

b) The packaging record Batch

The packaging record batch must be available for each The batch is packed. This document is based on the relevant part of the master packaging procedure in effect and the method of making these records is designed to prevent transcription errors. The record lists the number batch and the number of the planned product will be obtained.

Before a packaging activity begins, the inspection is done, that the equipment and the workplace have been free from the product and document Previously or unrequired materials for planned packaging, and clean and appropriate equipment for their use.

During the packaging, information as follows is recorded at the time each action is performed and after complete records are dated and signed with the consent of the personnel who be responsible for the packaging activities:

www.peraturan.go.id

2014, No. 79485

(1) product name;

(2) the date and time of each packaging activity;

(3) the name of the personnel responsible for carrying out the packaging activities;

(4) paraf of operators of various steps Significant packaging;

(5) examination records on identity and conformity with master packaging procedures including surveillance results during the process;

(6) details of the packaging activities performed, including equipment references and the packaging path is used;

(7) if possible, sample materials print gold in use, including specimens from batch codification, expiry date printing as well as all additional printing;

(8) notes on special issues that occurred including his description with the authorization signature for all storage of master packaging procedures; and

(9) the number and reference number or identification of all printed packaging materials and ruahan products that are submitted, used, destroyed or returned to the stock and number of products that was obtained to perform an adequate reconciliation.

g. Quality Supervision Documentation

Documentation in quality supervision includes:

1) The Sample Procedure Document

Documentation of the written procedure must be available for sampling that includes personnel authorized taking samples, methods, tools and containers that must be used, the number of samples that must be taken and any sample packaging action during the take which must be noticed to prevent contamination of the material that may decrease the quality of the quality (special clothing)

Must be held sample retrieval records for testing corresponds to the specified sample retrieval procedure. Default ingredient sampling record

www.peraturan.go.id

2014, No. 794 86

loading product code, supplier name, receipt date, batch batch checked raw materials, received raw materials, sample retrieval dates and sample number, while records for retrieval sample of products containing product names, checked product batch numbers, number of products in one batch or lot tested, sample retrieval dates and number of samples.

2) Test Procedure documents (including analysis worksheets and/or laboratory logbook)

The written testing procedure must be available to the testing of materials and products obtained from each production stage that describes the methods and tools that must be used. The testing procedures executed are noted.

The test records contain test dates, identification of materials, including product code, supplier name, date of receipt, batch batch checked raw materials, the amount of raw materials received, the date of sampling and number of samples, referral method of sampling the date and the signature of the testers and supervisors, the results of the results of the tests performed by the date, the pronunciation of the testers and supervisors, the dismay and the The rejection of the quality surveillance is on the signing of the handlers. answer, the certificate number issued.

The records must be made for the results of the examination and testing of the default bawan specification, the product between, the ruahan product and the product so, according to the method of testing should include the supposition or refusal to be accompanied by testing from the supervisor.

All quality surveillance documentation associated with the batch record is stored up to one year after the batch expiry date. For some types of data (e.g. test results analysis, tangible results, environmental monitoring) are created in such a way as to enable the implementation of trend evaluation. Next to information that is part of the batchnote, other original data such as laboratory records and/or recordings are stored and available.

Note ...

www.peraturan.go.id

2014, No. 79487

3) Procedure and Reception Notes

Written procedures and acceptance notes must be available for any initial material delivery, primary gold, and printed gold.

Notes reception includes:

a) the name of the material on the mailing and container name;

b) the name "internal" and/or material code, in terms of the material name not equal to the name of the material on the delivery letter and the container;

c) the acceptance date;

d) supplier name and, if possible, name of the creator;

e) number batch or referent maker;

f) the total number and number of accepted vessels;

g) the number batch provided after receipt; and

h) any relevant comments, e.g. the condition of the container when received.

4) the Procedure and the Notes Acceptance and acceptance of the terms of the Cloud Service. The rejection

a) Surgical Procedure and written rejection should be available for materials and products, especially the forestuation for product sales so by the Chief Management Officer of Mutu (Warranty of Mutu).

b) Notes on the distribution of each batch of products are stored to facilitate the withdrawal of the batch.

c) The written procedure and the related records regarding the action must be taken or the conclusion reached must be available, and applicable, for:

(1) validation, e.g. process, procedure, analysis procedures, compute systems;

(2) assembly of equipment, qualifications, and calibration;

(3) care, cleaning, and sanitation;

(4) the thing relating to personnel including training, clothing, hygiene;

(5) monitoring environment;

(6) pest control;

(7) complaints;

(8) withdrawrights; and

(9) change of product handling.

www.peraturan.go.id

2014, No. 794 88

h. Self Inspection Documentation (Internal Audit) and Mutu Audit

1) The written procedure must be available for internal inspection which includes an internal inspection list and inspection form, team arrangement, internal inspection schedule.

2) Notes must be made for the execution and results of self-inspection that includes evaluation, conclusion and necessary follow-up.

i. Documentation of complaint handling of the product, product recall, and Product Change

1) The procedure and handling of complaint handling

The written procedure document must be available for complaint handling, against the product, withdrawal returns the product, the return product and its continued actions are recorded and reported. If the product is to be destroyed, it is documented to include news of the extermination event being dated and signed by the personnel performing and personnel who witnessed the extermination.

The complaint of complaint and report includes:

a) the product name and number batch;

b) type of complaint and report;

c) where the source of the complaint or report;

d) the sample of the product is concerned;

e) the summary of the complaint or report;

f) the results of the investigation;

g) evaluations; and

h) the response and follow-up to the complaint or report.

2) The Procedure and Notes of the Fish Drug So

The procedure documents and written records must be available for the recall of a fish drug so a batch or lot or whole fish drug so on the market. The drug change record must be created and includes:

a) product name, number batch and the size batch;

b) the start date and the completion of the recall;

c) the reason for the recall;

d) the number of the remainder and amount that have been distributed from batch of products in question on the recall date;

www.peraturan.go.id

2014, No. 79489

e) the number of returned products;

f) where product origin is returned;

g) evaluation;

h) follow-up; and

i) the recall handling report includes reports to government, if required.

3) Procedure and Termination Materials and Rejected Products

The document documents and written records must be available for the destruction of the rejected materials and products that include prevarative measures environmental pollution and possible fall of the products concerned into the hands of people who do n' t Authorized. The extermination logs of the rejected materials and products must be made and include:

a) the name of the material or product, number batch, and the number annihilated;

b) the origin of the material or product;

c) the means of annihilation;

d) the officer's name who carried out and who witnessed annihilation; and

e) the extermination date.

j. Qualifying Documentation and Validation

1) a written validation protocol is created to detail the qualifications and validation to be performed. Protocols are reviewed and approved by the Chief Management Officer of Mutu (Mutu Warranty). The validation protocol details the critical step and receipt.

2) Created a report referring to the qualified protocol and/or validation protocol and contains a summary of the results obtained, a response to the deviation that occurred Conclusions and recommendations for improvement. Any change to the plan specified in the protocol is documented with appropriate consideration.

3) Once the qualification is completed is granted the written consent to be able to carry out the qualifying and validation stage next.

www.peraturan.go.id

2014, No. 794 90

4) Must be made a record of the validation results that load personnel performing, tool names or validated levels of assignment procedures, provided the validation result.

K. Qualification and Validation

1. The principle

CPOIB requires manufacturers of fish drugs to identify the validation that needs to be done as evidence of control to critical aspects of the activities performed. Significant changes to analysis, tools, and processes that can affect the quality of the product are validated. An approach with risk studies is used to define the scope and scope of validation.

2. Planning Validation

a. All of the validation activities are planned. The main elements of the validation program are detailed and are documented in the Validation Parent Plan (RIV) or equivalent document.

b. The Master Plan of Validation is a short, precise and clear document.

c. The Master Plan Validation includes at least the following data:

1) the validation policy;

2) the summary of the facility, system, equipment and processes to be validated;

3) the format of the document, which consists of a protocol format and Validation reports, planning, and execution schedules;

4) change control; and

5) reference the document used.

d. For a large project, the Validation Master Plan was created separately.

3. Qualification

a. Design qualification

1) The Design Qualifier is the main element in performing validation of new facilities, systems, or equipment.

2) The design meets the CPOIB ' s provisions and is documented.

b. Installation Qualification

www.peraturan.go.id

2014, No. 79491

1) The installation of installation is performed against new or modified facilities, systems, and equipment.

2) The installation of installation includes, but is not limited to the following:

a) equipment installation, The pipeline and means of support and maintenance are consistent with the specifications and engineering images designed;

b) the collection and drafting of the operating documents and equipment maintenance of the supplier;

c) the terms and calibration requirements; and

d) verification of construction materials.

c. Operational Qualification

1) The operational qualification is conducted after the installation of the installation is completed, reviewed and approved.

2) The operational qualification includes, but is not limited to the following:

a) testing which needs to be done based on the knowledge of processes, systems, and equipment; and

b) testing that includes one or more conditions that cover the top and lower operational limits, often known as the worst condition (worst case).

3) The formal completion of operational qualifications includes calibration, operating procedures and cleaning, operator training and preventive care provisions. Completion of the operational qualification of the facility, system and equipment is equipped with written consent.

d. Performance qualification

1) The performance qualification was performed after the qualifying installation and operational qualification was completed, studied, and approved.

2) The least performance Qualifiers include the following:

a) testing by using raw materials, a replacement material that meets the specifications or simulation products performed based on knowledge of the processes, facilities, systems and equipment; and

b) the test covering one or more conditions that include the upper and lower operational limits.

www.peraturan.go.id

2014, No. 794 92

3) Although performance qualifications are described as separate activities, in some cases the implementation can be put together with operational qualification.

e. Facilities, Appliances and Built-in Systems have Operational

Available evidence to support and verify operational parameters and the critical variable limit operation of the tool. In addition, calibration, operating procedures, cleaning, preventative care as well as procedure and operator training records are documented.

f. Process Validation

1) General

a) The provisions and principles described in this chapter apply to the preparation of the fish drug, which includes validation (initial validation) new process, validation in the event of process change, and Revalidation.

b) In general, process validation is performed before the product is marketed (prospective validation). Under certain circumstances, if the above is not possible, validation can also be performed during a routine production process (conkruen validation). The already running process is also validated (retrospective validation).

c) The facilities, systems and equipment used have been qualified and the analytical method is validated. Personnel who perform validation get appropriate training.

d) Facilities, systems, equipment and processes are evaluated periodically for verification that the facilities, systems, equipment and processes are still working properly.

2) Prospective Validation

a) The most prospective prospective Validation includes the following:

(1) a brief description of the process;

(2) critical stage summary of the making process to be investigated;

www.peraturan.go.id

2014, No. 79493

(3) the list of equipment/facilities used including the measuring device, monitoring and recording and status of its calipments;

(4) the product specifications so to be graduated;

(5) the list of appropriate analytical methods;

(6) the supervision proposal during the process and receipt criteria;

(7) additional testing to be performed including acceptance criteria and validation of the analysis methods, when required;

(8) sample pattern;

(9) the recording method and the evaluation of the results;

(10) function and responsibility; and

(11) proposed schedule.

b) Using procedures (including components) that have been specified, batch-batch sequentially can be produced in regular conditions. Theoretically, the number of production processes and observations has been sufficient to describe the variations and set the trend so that it can provide sufficient data for evaluation purposes. Generally, 3 (three) batch sequentially that meet approved parameters can be received have met the process validation requirements.

c) The size batch used in the validation process is the same as the size batch of production planned.

d) If batch validation will be marketed, the condition of its creation meets the provisions of the CPOIB, the validation results meet the specifications and according to the edar permit.

3) Validation Konkuren

a) In certain respects, Routine production may begin without first completing the validation program.

b) The decision to conduct conquenren validation is justified, documented and approved by the Chief of the Mutu Management Section (Mutu Warranty).

c) The documentation requirements for concuren validation are similar to prospective validation.

www.peraturan.go.id

2014, No. 794 94

4) Retrospective Validation

a) a retrospective Validation can only be performed for an already established process, but does not apply if there is a change in product formulas, creation procedures or equipment

b) Process validation is based on the product history. The validation phase requires the creation of a special protocol and data study results report to draw conclusions and provide recommendations.

c) The data source includes batch processing logs and the batch batch record, recording process supervision, tool care log book, personnel replacement records, process capability studies, product data so include trend data records and stability test results.

d) Batch selected for retrospective validation test represents entire batch made during the observation period, including those that do not meet specs, and in sufficient quantities to show the consistency of the process. Additional testing of the stilldeath sample may need to get the amount or type of data needed to perform a retrospective validation process.

e) In general, retrospective validation requires data from 10 (ten) to 30 (three batch sequentially to assess the consistency of the process, but the number batch is slightly less possible if it can be justified.

5) The Cleaned Validation

a) cleansing validation is performed for the confirmation of effectiveness Cleaning procedure. The determination of the limits of the residues of a product, cleaning materials and microbial pollution, is rationally based on the material associated with the cleaning process. Such limits can be achieved and verified.

b) used a validated analysis method that has the sensitivity to detect residues or spruce. The detection limit of each analytical method is sensitive enough to detect the level of residues or an acceptable amount of exposure.

c) cleansing validation is done only to the surface of the tool that comes directly with the product.

www.peraturan.go.id

2014, No. 79495

is considered also for the part of the tool that does not contact directly with the product. The time interval between the use of the tool and the cleaning is validated as well as between cleaning and reuse. determined method and cleaning interval.

d) The cleaning procedure for similar products and processes, can be considered for selecting a range that represents similar products and processes. One validation study can be performed using the worst-condition approach with regard to critical issues.

e) validation of cleaning procedures is performed by performing procedures three consecutive times with eligible results for Proving that the method has been validated.

f) the test until clean is not the only option to perform clean-up validation.

g) in certain circumstances the product has the same physical-chemical properties removed for simulation replacing a product, with the condition of the replacement ingredient not toxic or dangerous.

6) Change Control

a) is available a written procedure detailing the steps taken if there are any changes to the initial materials, product components, process equipment, work environment (or factories), the method Production or testing, or any changes or changes that affect the quality or reproducible of the process. Change control procedures ensure that supporting data is sufficient to show that the repaired process results in a product according to the desired quality and is consistent with the specified specifications.

b) all the way changes that may affect the quality of the product or reproducability of the process are officially submitted, documented and approved. The possible impact of changing facilities, systems and equipment against products is evaluated, including risk analysis. determined the needs and coverage to conduct qualification and revalidation.

www.peraturan.go.id

2014, No. 794 96

7) Validation

periodically the facilities, systems, equipment and processes including the cleaning process are evaluated for confirmation that validation is still ablegitimate. If there is no significant change in its validity status, a review of the data shows that the facilities, systems, equipment and processes meet the requirements for revalidation.

8) Validation of the Analysis Method

The purpose of validation The analytical method is to find out that the analytical method is appropriate for its use.

9) The Validation Method of Analysis

a) Validation of analytical methods is generally performed against 4 types:

(1) identification tests;

(2) quantitative impurity test (impurity);

(3) border test impurities; and

(4) the quantitative test of active substances in samples of materials or fish drugs or certain components in fish drugs.

b) Other analytical methods, such as test disolution for fish drugs or particle determination for active raw materials, also validated.

c) A brief description of the analysis method test type is as follows:

(1) The identification test aims to ensure the identity of the analyte in the sample. This test is usually done by comparing sample characteristics (e.g., spectra, chromatogram profiles, chemical reactions, etc.) against the default.

(2) Testing of impurities may be performed via a quantitative test or a boundary test. The impurity in the sample. Both tests aim to reflect precisely the characteristic purity of the sample. Different validation characteristics are required for quantitative tests rather than for the impurities test.

(3) The level of penetration is intended to determine the levels of the analyte in the sample. in this case the designation of the level indicates the main component contained

www.peraturan.go.id

2014, No. 79497

in active material. for fish drugs, similar validation characteristics also apply to the designation of an active substance content or a particular component. The same validation characteristics can also be performed for the assignment of the levels related to other analytical methods (missal disolution).

d) The method of analysis is clear and easy to understand as this will determine the validation characteristic that needs to be evaluated. Typical validation characteristics are as follows:

(1) accuracy;

(2) precision;

(3) reapatability;

(4) intermediate precision;

(5) specifities;

(6) detection limit;

(7) cuantation limit;

(8) linearity; and

(9) range.

e) Validation is required under the following conditions:

(1) the change in the source of active materials;

(2) changes in the composition of the product so; and

(3) changes to the analysis method.

f) The required revalidation rate depends on The nature of the change.

THE MINISTER OF MARINE AND FISHERIES

REPUBLIC OF INDONESIA,

SHARIF C. SUTARDJO

e) Validation ...

www.peraturan.go.id

2014, No. 794 98

ANNEX II

REGULATION OF MARINE AND FISHERY MINISTER REPUBLIC OF INDONESIA

NUMBER 24 /PERMEN-2014

ABOUT

THE WAY OF GOOD FISH MEDICINE

FORM DATA REQUIREMENTS CPOIB

I. THE APPLICANT ' S IDENTITY

1. Name:

2. Tax (NPWP):

3. The Company ' s Establishment Akte Number:

4. Company handler name

:

5. Address:

II. CPOIB REQUIREMENTS

1. Quality management

a. Quality assurance: there is no

b. Product Quality Review: ada/nothing

2. Personia

a. Organization Structure: there is no

b. The task description of each manager and supervisor/

supervisor: ada/nothing

c. The position of the quality control manager

and the Mutu installers: there is no /no-be-down

d. Production Manager Title: there is no /no-down

e. Quality supervisors/supervisors of quality supervision: there is no /no-be-down

f. The post of production/production supervisors: there is no/no-be-captured

g. Office Engineer: ada/nothing

h. Employee Health History: there is no

i. The CPOIB Training Program or equivalent: ada/none

j. CPOIB or equivalent training certificate: ada/none

3. Buildings and Facilities

a. Factory building area: // m2

www.peraturan.go.id

2014, No. 79499

b. Set the space (conformity of activities one with the other): something/not appropriate

c. Wall surfaces and room floors correspond to the product type: something/not appropriate

d. The storage/storage area layout :some/not appropriate

e. The lighting in the production space :enough /not enough

f. Airbending and ventilation :enough /not enough

g. Room cleaning program: ada/none

h. Production layout and quality control (aseptical

area/clean area/grey area/black area/other): ada/none

i. Building maintenance and repair programs: ada/none

4. Equipment

a. Electrical equipment: put it out/not

b. Tool and tool check: ada/nothing

c. Equipment maintenance schedule: ada/nothing

d. Equipment logging and cleaning equipment: ada/nothing

e. Equipment maintenance record: there is no

f. Repair record and equipment malfunction: ada/none

g. Equipment maintenance and repair programs: ada/none

h. Tool work instruction: ada/none

5. Sanitation and Hygiene

a. Health check program: ada/nothing

b. SOP application of individual hygiene: ada/nothing

c. The body protection uniform usage schedule corresponds to

the room and the degree of hygiene: ada/nothing

d. SOP washing hands: ada/none

e. Hand-washing poster: ada/nothing

f. List of some cleaning materials various means of building: ada/nothing

g. SOP sanitation room: ada/none

h. Production room disinfectant and disinfectant: ada/none

i. Production room cleaning tool: ada/none

j. Labels and equipment hygiene inspection forms before

use: ada/none

www.peraturan.go.id

2014, No. 794 100

6. Production

a. Drug Production SOP: ada/do not exist

b. SOP and scale calibration notes: ada/none

c. SOP and rebalancing logging: ada/none

d. Program and record validation: there is no

e. Tool tags (have been cleared, broken, etc.): ada/none

f. SOP and record awarding number batch : ada/none

g. SOP and record requisition raw materials: ada/nothing

h. SOP and logging requisition materials: ada/none

i. SOP and packaging record: ada/none

j. SOP and logging extermination of packaging/ruahan products

and fish drugs so that are not eligible: ada/none

k. The fish-drug quarantine label so: ada/nothing

l. The form of a fish drug submission so: ada/nothing

m. SOP and record receipts, expenses, and rest

preliminary materials: ada/none

7. Quality Surveillance

a. Test laboratory layout test: ada/none

b. The program and record validation method of analysis: ada/nothing

c. SOP and potential testing of potential/microbiology: ada/none

d. SOP and environmental monitoring record

with the breeding media cawan: ada/none *)

e. SOP and sample retrieval records

f. SOP and report investigation failure batch : ada/none

g. Program, SOP, and stability testing report: ada/none

h. SOP assessment of the installer

initial materials: ada/none

8. Self-Inspection (Internal Audit) and Mutu Audit

a. SOP and self inspection report: ada/none

b. SOP and quality audit report: ada/none

9. Handling of the complaint against the product, retraction of the product, and the change product

a. SOP and the fish drug distribution record so: ada/nothing

b. SOP, notes, and a report of retraction of fish drugs so: there/no/no

c. SOP, notes, and complaint reports: ada/none

d. SOP and change fish drug note: ada/none

e. SOP and the extermination record of the initial materials: ada/none

f. SOP and the culling records of fish drugs so: ada/nothing

www.peraturan.go.id

2014, No. 794101

g. Initial material extermination event: no /no

h. News show eradication of fish drugs so: ada/none

10.Documentation

a. Document form (batch record blank): ada/none

b. Initial materials specification: ada/none

c. Specification of gold materials: ada/none

d. Fish drug specification so: ada/nothing

e. Fish drug documents so: ada/none

f. Parent production document: ada/none

g. SOP and master processing records: ada/none

h. SOP and master packaging note: ada/none

i. batch processing note (from initial material rebalancing/d

delivery of the fish drug into warehouse): ada/nothing

j. Methods of raw materials testing: ada/none

k. Space product testing method: ada/none

l. Sample retrieval logs (in parent formula): ada/none

m. Stock/stock inventory card: ada/nothing

o. Inventory/gold card: ada/nothing

p. Space product supply card: ada/none

q. Quarantine supply card: ada/none

r. Fish drug supply cards so: ada/none

s. CPOIB native certificate or equivalent: ada/none

11. Qualifications and Validation

a. Validation master plan: ada/nothing

b. Design and installation qualifications: ada/do not exist

c. Operational qualification: ada/none

d. Qualification of facilities, equipment, and installed systems

e. which has been operational: ada/none

f. Process Validation: there is no

g. Toolkit validation program: there is no

h. Validation of sanitary and hygienic procedures: ada/none

www.peraturan.go.id

2014, No. 794 102

III. FISH DRUG DATA PRODUCED

No. Type of Supplies

Forms of supplies

(Serbuk, Cair, Tablet, Others)

The Production Capacity Drug Name Composition

1. Biologics

2. Farmasetic.

a. antibiotic

b.non antibiotic

3. A premix can be

a. feed additive

b. feed suplement

4. Probiotic supplies

5. Natural medicine

*) If nothing, explain the reason

MINISTER OF MARINE AND FISHERIES

REPUBLIC OF INDONESIA,

SHARIF C. SUTARDJO

SHEET OF CONSENT

NO PARAF TITLE

1. General Secretary

www.peraturan.go.id

2014, No. 794103

ANNEX III REGULATIONS MINISTER OF MARINE AND FISHERY REPUBLIC INDONESIA NUMBER 24 /KP/2014 ON THE WAY OF MAKING GOOD FISH MEDICINE

Jakarta, Director General Fisheries Cultivation, Director General of Aquaculture,

Name Name

MINISTER OF MARINE AND FISHERY

REPUBLIC OF INDONESIA,

SHARIF C. SUTARDJO

Certificate Number: Certificate Number

Owner/Company Name: Owner/Company

Company Responsibilities Name: Company Responsibility

Owner/Company Address: Address

Factory Address: Factory Address

Permission Number Provision of Manufacturing Licence :

Types and Forms of Supplies: Product and Dosage Form

Applicable to: Valid until

This certificate is invalid if there is a change to the requirements that result in not being provided with the provisions of the Good Fish Drug Making. This certificate will not be valid in case of any changes which affected to the condition causing conditions of Good Manufacturing Practices.

MINISTRY OF MARINE AND FISHERIES DIRECTORATE GENERAL FISHERIES CULTIVATION

CERTIFICATE A CERTIFICATE