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Attachment VII.17 (Example)

PRODUCT STOCK CARD SO

THE COMPANY NAME.

PRODUCT CARD SO

THE CODE NUMBER. PRODUCT NAME

. ♪ UNIT. ♪ Enter

EXIT

TGL NUMBER BETS

JML (Pot)

TGL NUMBER BETS

DISTRIBUTOR JML (Pot)

SISA Paraf/Attraction

17/3 10ABD 1000 1000 18/3 11bgf 1000 2000

18/3 10ABD PT.AWUT 1000 1000

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Attachment VII.18 (Example)

DEFAULT OPERATING PROCEDURE

HANDLING OF THE PRODUCT IS NOT APPROPRIATE

Page 1 of 2 DEFAULT OPERATING PROCEDURE FOR PRODUCT HANDLING IS NOT APPROPRIATE

NAME COMPANY

. PART

SEXY

.

Number 8 ..........

The date applies ........

Composed by a ... Date.

Rechecked by ... The date of the event is:

Approved by a ... Date.

Replace the Number of ........ Date:

1. PURPOSE

Provide clues as to the actions taken in the event of a perversion of the quality of the product in both chemical and microbiological aspects.

2. SCOPE

This action applies to: basic materials of supplies/base and ruahan products, the product becomes. 3. PROCEDURE

3.1. Ruahan and Product Antara (Base Materials/Base Materials) 3.1.1. The Ruahan and Product Antara (Base Materials) products are rejected due to

the inconsistency of the physical aspects of chemistry, after an improvement in accordance with the limits allowed to be performed as follows: a. After the results of analysis and identification are known to cause inconsistency,

can be re-process after receiving permission from the Factory Leader. Products that have been completed are reprocessed.

b. Destroyed in accordance with the internal procedures at the factory. In the case of microbiology of a ruahan product, the Mutu Surveillance Section is tasked with finding and finding the cause of the conflict. When it is possible to decontaminate, the bulk product can be processed. If it is not possible to decontaminate the product must be destroyed and this action is informed to the factory leader.

3.1.2. Quality inconsistation of the quality products and the product between (the base of the supplies) after the validity date of the test pass. If a result of a ruahan product or a product intermediate (base-to-base material) is rejected due to the incompatibility of chemical physics or microbiology after the validity pass of the test, the bets of the product are destroyed in accordance with the internal procedure. It's in the factory.

3.2. Pre-loaded and packaged products

3.2.1. If this quality inconsistency is observed at the time of the connection to the charging line, the filling activity is terminated immediately. Analysis of the cause, such as connection errors, problems during storage, problems with errors in transfer equipment and others, must be done by the related sections. Products that are pre-contained and packaged before problem solving must be destroyed in accordance with the internal procedure.

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Page 2 of 2 DEFAULT OPERATING PROCEDURE PROCEDURE NOT APPROPRIATE

COMPANY NAME

PART

SEXY

.

Number 8 ..........

The date applies ........

Composed by a ... Date.

Rechecked by ... The date of the event is:

Approved by a ... Date.

Replace the Number of ........ Date of.

3.2.2. The quality of the quality of the product is already contained and packaged. The rejection of the whole or part of the pack of products that is already contained or packaged is based on aspects of chemical physics and microbiology will lead to the destruction of some or all of the bets. This is the basis for a further investigation by the Mutu Surveillance Section. If possible correctable action is possible, especially in the process of charging and packaging that are directly affected by quality, such as solid product violence/compact product/compact, ballast of lipstick and others.

3.2.3. Treatment of decontamination of products that are already contained or packaged.

After receiving approval from the factory leadership, the decontamination process may be processed from contaminated bets. This decontamination process should not affect the physical properties of the chemical products of ruahan or for the material of gold. All products that have undergone decontamination must be retested in chemistry or microbiology before the product can be distributed to the market. The parameters to analyze the decontaminated product must be conducted a preliminary test by the Mutu Surveillance Section. Quality control should inform the party of the outcome of the retreatment of the product so. An act of correction must be made in any conflict of the results of a microbiology test.

3.2.4. The inconsistency of the results of the microbiology of the material for the gold if there is a conflict of the microbiology of the gold, may be a correction until the supplier can meet the requirements of the microbiology that has been established by the microbiology. the factory. Quality Surveillance provides advice on correcting actions to improve the cleanliness of the microbiology.

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VIII. QUALITY CONTROL

1. Introduction

Quality control is all examination and testing efforts made before, during and after cosmetic making to ensure that cosmetics are produced continuously meet the established requirements. When there is no test facility available, it can be tested by designating an accredited laboratory. In order to ensure freedom in order to determine its decision, the Mutu Surveillance Section is a separate part of the production section. 1.1 Quality Monitoring System

Quality monitoring system includes: 1.1.1 System and sampling procedures, testing, checking of

initial materials, intermediate products, ruahan products, products and products and conditions environment in the framework/refusal of /refusal/monitoring to meet specified requirements.

1.1.2 The laboratory building was designed to be built in accordance with

the following among others: 1.1.2.1 The laboratory size and the layout space

The testing laboratory is designed to wake up, fitted equipment and has adequate space so it can accommodate all necessary activities with adequate working comfort.

1.1.2.2 Provided a suitable and safe place for garbage and the rest of the material to be disposed of in a closed container meeting and given a clear sign that states the type and the waste risk class. Toxic materials and flammable materials are stored in a specially designed and separate place.

1.1.2.3 The laboratory room is not in the production space, but can be adjacent to the production space, free of spruce and vibrations that can be influential to test results.

1.1.2.4 Physical chemical laboratory space, microbiology and instruments are separated from each other to avoid contamination.

1.1.2.5 Laboratory Design, pay attention to 1.1.2.5.1 The building materials were used. 1.1.2.5.2 The gas flow and the harmful fumes to the outside (cupboard

acids). 1.1.2.5.3 Ventilation. 1.1.2.5.4 separate airbender unit for the laboratory

microbiology. 1.1.2.6 Let ' s provided:

1.1.2.6.1 The test material rebalancing. 1.1.2.6.2 solvent and reagent storage. 1.1.2.6.3 Area of the example of an example of an example. 1.1.2.6.4 The standard repository of initial materials and sparring

products so.

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The example of the Quality Surveillance Laboratory layout is listed in the VIII.1 Attachment.

1.1.3 Personalia

Each personnel be able to wear protective clothing and safety devices according to their tasks and activities among other protective glasses, masks, and gloves. For that it needs to be made the Baku Operational Procedure (POB) of the intended Work Safety Equipment.

Example POB Use and Maintenance of the Eye Shoppers Are Listed in the VIII.2 Attachment. Examples of Work Instruction (IK) The way the Respirator for Organic Materials is listed in the VIII.3 Attachment.

1.1.4 Equipment

1.1.4.1 Equipment and laboratory instruments testing let in accordance with the initial materials Testing Procedure and product.

1.1.4.2 Available IK operating every instrument and equipment that be placed near the instrument or equipment in question.

1.1.4.3 The equipment and the instrument are treated and calibrated periodically and the implementation is documented. The calibration label should be shown on each instrument.

1.1.4.4 The equipment that does not function properly or is being treated is clearly marked and should not be used before it is fixed.

Example POB Calibration pH The meter is listed in Annex VIII.4. Examples of IK Use of the pH of the meter are listed in the VIII.5 Attachment. Examples of Appliance Status tags are listed in the VIII.6 Attachment.

1.1.5 Perestunt and Media Pembiakan

1.1.5.1 Reception, reagent creation, breeding medium and manner of measurement are composed of POB as well as the results of the implementation are noted.

1.1.5.2 The reagent is made in the laboratory Let the appropriate label be provided: concentrate, standardization factor, usage deadline, reset date, date of creation and signature of the officer who created.

Example, Record Making of Usurpation, and The breeding media is listed in Appendix VIII.7. Examples of Container Solutions and Container Solutions and the Titer Solution Labels are listed in the VIII.8 Attachment.

1.1.6 Specifications and Testing Procedures

1.1.6.1 The Test Procedure should refer to the existing compendia (for the raw materials), if not allowing the procedure to be guaranteed its validity with regard to the the existing equipment facility, which must be approved, signed, and is given a date by the Head of the Mutu Surveillance Section.

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1.1.6.2 Specifications are a list of test parameters, referring to the Test Procedure, as well as the appropriate acceptance criteria for the numerical limit, range or other criteria for the test in question, which must be approved, signed, and dated by the Chief of the Mutu Surveillance.

1.1.6.3 Any initial material, the product between, the product of ruahan and the product so let the specifications and Test Procedure detailed and written.

1.1.6.4 Specifications let include among others: 1.1.6.4.1 Material Name The beginning/product. 1.1.6.4.2 Initial ingredient/product number. 1.1.6.4.3 The description of the container and packaging. 1.1.6.4.4 qualitative and quantitative requirements with the limits

of its acceptance. 1.1.6.4.5 examples of sampling and testing or reference of

approved test procedures. 1.1.6.4.6% of expiring (if any) test. 1.1.6.4.7 The way of storage.

1.1.6.5 Any deviation from the specified Test Procedure must be reported as well as approved by the Head of the Mutu Surveillance Section before it is exercised.

1.1.6.6 The test results, especially those It concerns the calculation, be checked by the supervisor, before it is reported to the Chief Oversight of Mutu.

Example Specification of Raw Materials and Goldingredients is listed in the VIII.9 Annex.

1.1.7 Evaluation of Production Procedure by the Mutu Surveillance Section.

1.1.7.1 The Mutu Supervision Section may participate in the creation of the Parent Processing Procedure (listed on the VII.9 attachment) and The Master of the Master's Pacing Procedure (listed on the VII.13 appendix) a product to guarantee the uniformity of the bets to the bets produced. Any change and adjustment to the Master Processing Procedure or the Master's packaging procedure must be approved by the Production Part responsible and responsible for the Mutu Surveillance Section before being used by the Production Section.

1.1.7.2 Quality Oversight provides POB The Purge and Sanitation Buildings (listed on the VI.9 attachment) and POB Cleaning and Sanitation of Production Equipment (listed on the VI.13 attachment.)

1.1.8 Analysis Note and Test Results Report

1.1.8.1 Act Be Made analysis record and test results report on the initial materials and products according to the approved testing method.

1.1.8.2 The analysis and test results report is the official laboratory document that must be stored as well as the Properly maintained that is easily and quickly rediscovered when needed.

1.1.8.3 Notes analysis let include among others: 1.1.8.3.1 Name and betting number instance.

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1.1.8.3.2 The officer ' s name is taking the example. 1.1.8.3.3 The analytical method used. 1.1.8.3.4 All analysis data such as weights, buret readings, volume

and dilution. 1.1.8.3.5 calculation in unit size and formula used. 1.1.8.3.6 Statement of whether fulfilling or not fulfilling

specification requirements. 1.1.8.3.7 The date and the signature of the officer performing the testing

and the officer who examined the calculations. 1.1.8.3.8 Statement of whether passed or rejected as well as advice

regarding the next act signed and given the date by the authorized officer.

1.1.8.3.9 The supplier's name, the amount of initial materials received and the number of products which is produced.

1.1.8.3.10 The number of examples taken from each of the initial materials and products analyzed.

1.1.8.3.11 The number of bets or lot numbers of the starting materials/products analyzed.

1.1.8.4 Note analysis of each testing done

be made in sheet form or in in a book numbered in his page number to make sure that there are no pages or sections of the analysis missing.

1.1.8.5 The certificate of analysis is a report of testing results that meet the specifications and let it load the thing following: 1.1.8.5.1 The name and address of the factory or the institution that publishes

the certificate. 1.1.8.5.2 The certificate number. 1.1.8.5.3 Name of materials or products and forms of supplies. 1.1.8.5.4 Of The points of bets of materials or products. 1.1.8.5.5 Test results and standard limit value. 1.1.8.5.6 The Date and the signature of the Mutu Surveillance Section.

Example the Analysis Certificate is listed in the VIII.10 Attachment. 1.1.9 Assessment Against Supplier

1.1.9.1 The Mutu Supervision Section should be responsible alongside the relevant section to select a capable and trustworthy supplier in the provision of the initial materials that meet the specifications has been set, timely and exact number.

1.1.9.2 Assessment against all suppliers candidates let it be done before being ordered/order.

1.1.9.3 The assessment is performed jointly by the representative of the Mutu Surveillance Section, Production Section and Purchase Section to set the eligible supplier.

1.1.9.4 Assessment against all suppliers let it be done periodically.

Example POB Evaluation and Supplier Assessment are listed in Annex VIII.11

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1.2 The supervision of the Mutu includes:

1.2.1 Example, inspection and testing. 1.2.1.1 The sampling.

Taking an example is an important activity because only a small fraction of one of the bets is taken for quality testing. Overall the validity of the conclusions on product quality is based on the testing done on the example representing one of the bets. Therefore, the number of sampling should be based on the statistical method.

1.2.1.1.1 The sampling officer should be trained on the proper method of sampling at the beginning of the exchange, and further evaluated. Its ability is periodic.

1.2.1.1.2 The sampling is performed according to the POB which

includes: 1.2.1.1.2.1 The example sampling method. 1.2.1.1.2.2 The number of examples taken.

The weight or sample volume of raw materials the product is taken should be sufficient for a minimum of two test complete specifications specified. The number of products that have been taken as an example should be sufficient for the final test required to pass the test, plus the amount stored as an example of the death including for a stability test if necessary.

1.2.1.1.2.3 The tool used in the sampling let it be clean. If taking an example of different bets let the new tool be used or purged before.

1.2.1.1.2.4 The type and conditions of the sample container are used should be made of glass, plastic or stainless steel that is would have no effect on the quality of materials or products at direct contact time.

1.2.1.1.2.5 Identification of the sample container. 1.2.1.1.2.6 Instruction to re-seal the container immediately after

sampling as well as being given tagging stating that the example has been taken from the container in question.

1.2.1.1.2.7 Special actions for sampling hazardous materials.

1.2.1.1.2.8 Instruction for cleaning and storage tool-sampling tools.

1.2.1.1.3 For identity testing let go the take

sample of the raw materials from each received container. 1.2.1.1.4 For complete analysis testing can be shot

example using the default sampling method

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existing (e.g. by √n + 1 method, √n or other statistical methods such as Military Standard 105D).

Examples of IK Sampling Materials of Baku and Gold Materials are listed in the VIII.12 Attachment. An example of an example of an example of a product in the Cloud Service is provided by IBM. An example of an example of a Product sampling so as set forth in the VIII.14 Attachment. Examples of IK Examination of Baku Materials are listed in the VIII.15 Attachment. An example of IK Examination of Gold Material is listed in Appendix VIII.16. Example IK Examination In Process Control (IPC) Skin Treatment/Hair Care/Shower Supplies are listed in Annex VIII.17.

1.2.1.2 Examination and testing of initial materials, intermediate products, ruahan products

and products so fit their respective specifications. 1.2.1.2.1 Default Materials.

1.2.1.2.1.1 Each raw material is tested against predetermined specifications, such as identity, purity and other requirements that have been established.

1.2.1.2.1.2 Only the raw materials are eligible that can be used for the production process.

1.2.1.2.1.3 The raw materials that are not eligible are separated by the storage and are labeled "REJECTED".

1.2.1.2.1.4 Rejected raw materials may be immediately returned to suppliers or exterminated in place, to prevent errors.

1.2.1.2.2 Gold Substances.

1.2.1.2.2.1 The forerage of gold is satisfied. The specified specifications for example the suitability of materials type, weight, function and design.

1.2.1.2.2.2 critical physical worms and which have a significant impact on the quality of the product were noticed.

1.2.1.2.3 Product Between and Product Ruahan.

1.2.1.2.3.1 To guarantee the uniformity and tenacity of the bets, the scrutiny in process should be done by taking an example that represents each of the bets.

1.2.1.2.3.2 The stored old product must be retested against the specification if it will be processed further.

1.2.1.2.3.3 Products that are not meets the specifications to be thoroughly investigated and the cause of failure must be determined. Further process

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must get the approval of the Mutu Surveillance Section.

1.2.1.2.3.4 The product to be reprocessed should be flagged and placed in quarantine area until it gets approval from Section Quality oversight.

1.2.1.2.3.5 The rejected product should be marked "REJECTED" and supervised for extermination.

1.2.1.2.4 Product So.

1.2.1.2.4.1 Any product bets let the test be done according to specifications which is set.

1.2.1.2.4.2 Bets products that do not meet the product specifications So the specified tag is "REJECTED".

1.2.1.2.4.3 A product that does not meet the specifications should be thoroughly investigated and the cause of failure must be determined. The further process must be obtained from the Mutu Surveillance Section.

1.2.1.2.4.4 The product to be reprocessed should be flagged and placed in the quarantine area until the approval of the Mutu Surveillance Section is approved.

1.2.1.2.4.5 Reprocessing Products must meet all specifications and other quality requirements specified before being passed for distribution.

1.2.1.2.4.6 The rejected product must be marked "REJECTED" and supervised to be performed extermination.

1.2.1.2.5 Supervision During Processing.

Surveillance during processing is aimed at preventing the region's production of products that do not meet the specifications. Supervision is done by taking an example, holding checks and testing against products produced on certain steps of the processing process.

1.2.1.2.6 Surveillance During The packaging.

1.2.1.2.6.1 Only Ruahan products that have met the requirements that are allowed to be packaged.

1.2.1.2.6.2 Examination and testing during packaging are performed periodically and are taken examples of minimal products at the beginning, middle, and end of the packaging.

1.2.1.2.6.3 The pre-packaged product should be quarantined until it is passed by the Mutu Surveillance Section.

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1.2.1.2.7 Retesting of Materials or Products Approved. 1.2.1.2.7.1 Any initial materials, intermediate products, ruahan products

and products so let set the appropriate storage time limit.

1.2.1.2.7.2 After passing the storage time limit, the material or the product must be retested.

1.2.1.2.7.3 If a material or product is subjected to unsuitable storage conditions should be retested prior to use.

1.2.2. Programs and other activities related to the product quality, namely:

1.2.2.1 The supervision and monitoring of the working environment is: 1.2.2.1.1 Monitoring regularly against the water quality used

in the product processing It is chemically, physics and microbiology.

1.2.2.1.2 The periodic monitoring of the production environment is, in a state of production and non-production. Monitoring is done among other things against temperature, humidity, dust particles, microbes, vibration and noise levels.

1.2.2.1.3 Supervision of the pollution surrounding the plant's location e.g. insects, birds, rodents and others- other.

1.2.2.1.4 Surveillance against possible spruce from personnel working for example does not wash hands, not using gloves, not using masks, dirty work clothes and others.

1.2.2.2 The study of Bets Creation documentation.

1.2.2.2.1 All production records and quality oversight of each product's bets so be examined by the Mutu Surveillance Section to determine if the making of the bets is concerned satisfy all pre-defined procedures for distribution.

1.2.2.2.2 Any bets that deviate or fail to meet the specifications are thoroughly investigated. A written report on the investigation may be made, accompanied by conclusions and follow-up.

Example of the Report of the Investigation of the Bets Failure was listed in Annex VIII.18.

1.2.2.3 The sample monitoring program was intended to live.

1.2.2.3.1 The term was intended for reference to product stability as well as referrals when receiving customer complaints.

1.2.2.3.2 In the investigation of the example of the death The following common provisions are: 1.2.2.3.2.1 The example of a special death for raw materials

be given a clear identity and saved

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in a closed container meeting under specified conditions, for at least one year after the expiration date.

1.2.2.3.2.2 Examples of product soals so in complete packaging form such as that It is marketed which represents each of the bets, which is kept for at least one year after the expiration date. Examples of these products are stored in the same condition as the conditions indicated on the label.

1.2.2.3.2.3 For products so that a large packaging size can be represented by a small packaging of the same bets as the ingredients specification The same gold.

1.2.2.3.2.4 The number of examples of the death is at least twice the amount required for complete testing.

1.2.2.3.2.5 Examination organolechrists should be done before the example of the example Die.

Example POB Handling Sample Perresidences are listed in the Attachment VIII.19.

1.2.2.4 Quality Monitoring products located at the circulation

1.2.2.4.1 The existing products on the circulation are monitored periodically together with the Marketing Section.

1.2.2.4.2 The monitoring results are evaluated, documented and reported to the related sections as feedback in performing a continuous improvement.

1.2.2.5 The stability research program.

1.2.2.5.1 It was designed for the stability research program for know the stability of a product and determine suitable storage conditions as well as Product expiration date.

1.2.2.5.2 The stability research program is considering: 1.2.2.5.2.1 The number of bets for different bets sizes. 1.2.2.5.2.2 The number of examples.1.2.2.5.2.3 The test schedule. 1.2.2.5.2.4 storage conditions.1.2.2.5.2.5 A specific, meaningful and reliable testing of

.1.2.2.5.2.6 The product's completion is to be tested, at least in

The same primary packaging as the packaging will be marketed.

1.2.2.5.3 The stability research is done in the following: 1.2.2.5.3.1 New products (generally done on bets

experiments with the use of stability tests accelerated and at room temperature).

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1.2.2.5.3.2 Replace or augting the different primary packaging materials by specified standard.

1.2.2.5.3.3 Changes to formula, processing method and manufacturer of raw materials.

1.2.2.5.3.4 Bets being passed with exceptions is through reprocessing.

1.2.2.5.3.5 For outstanding products, stability research is done at room temperature.

Example the Stability Test is listed in the VIII.20 Annex. Examples of the Stability Test Report are listed in Appendix VIII.21.

1.2.2.6 The initial materials and product specification specifications.

1.2.2.6.1 Each specification of the initial material, the intermediate product, ruahan product and the product so let it be approved and stored by the Mutu Surveillance Section. Items covered in the initial materials specification, intermediate products, ruahan products and products so can be seen in the Documentation Chapter concerning the specification (Chapter IX grains 2). If the periodic revision is required to take note of the other reference documents.

1.2.2.6.2 Specifications are compiled by the Mutu Surveillance Section in accordance with the product development data and desired quality level.

1.3 Enough clear.

2. Reprocessing

2.1 The method of reprocessing is constantly evaluated to ensure that the product quality meets the product specifications so.

Reprocessing of a product ' s bets can be considered only if have been done at risk evaluation.

The product is a reprocessing let always be monitored its quality and stability.

The method of reprocessing is passed specifically by the Head of Production and Head of the Mutu Surveillance Section and must be fully documented. All changes must be recorded in the product bets note.

2.2 Quite clear.

3. Change (s):