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ASEAN GMP TRAINING MODULE PRODUCTION

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Presentation on theme: "ASEAN GMP TRAINING MODULE PRODUCTION"— Presentation transcript:

1 ASEAN GMP TRAINING MODULE PRODUCTION
Prepared by Mr. Haryanto Susilo - Indonesia Ms. Yupa Tiengthavaj - Thailand Mr. Vo Van Duc - Vietnam Approved by GMP Cosmetic ASEAN team Endorsed by ASEAN Cosmetic Committee Module 6 GMP Workshop Kuala Lumpur 14 – 16 November 2005

2 CONTENT OF PRESENTATION
Introduction Objectives Scope of production activity Basic description of production activity Production mapping and flow chart The Starting Materials Production Procedures Dry Products Wet Products Aerosol Products Finished Products Production Documents References Module 6 GMP Workshop Kuala Lumpur November 2005

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INTRODUCTION Module 6 GMP Workshop Kuala Lumpur November 2005

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OBJECTIVES To manufacture good & safe products and to deliver products with good efficacies To standardize all actions related to production activities. To ensure the consistency of product quality by using only approved starting materials To identify production activities, enable follow up and traceability To avoid cross-contamination and microbial contamination in production To avoid any error in production Module 6 GMP Workshop Kuala Lumpur November 2005

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SCOPE Production activities consist of the following : receiving & recording of starting materials sampling of starting materials preparation of production documents, including master formula weighing activities cleaning & sanitization of equipment preparation of bulk filling & packing activities reconciliation of production output proper recording of each activities to ensure traceability of finished products quarantine and delivery to warehouse reprocessing, if necessary Activities in production cover various aspects . Starting form reception, sampling , preparation , weighing raw materials , bulk preparation , filling & packing et. Each of these activities need a standard Operation procedure Module 6 GMP Workshop Kuala Lumpur November 2005

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BASIC DESCRIPTIONS PRODUCTION is defined as all activities starting from processing to packaging to obtain finished products PROCESSING is part of production cycle starting from weighing of raw materials to obtain a bulk product PACKAGING is part of production cycle starting from bulk product to obtain the finished product STARTING MATERIALS consist of raw materials and packaging materials used in the production of cosmetic products Module 6 GMP Workshop Kuala Lumpur November 2005

7 Raw material preparation
PRODUCTION MAPPING Raw material preparation Weighing Production operations must follow clearly defined procedures in accordance with approved specifications, with the objective of obtaining products of desired quality. Bulk storage Processing Production activities start from : preparation of raw materials weighing of raw materials mixing & bulk preparation filling and packaging to obtain finished cosmetic products that can be released to the market. Delivery to warehouse Filling & packing Module 6 GMP Workshop Kuala Lumpur November 2005

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PRODUCTION FLOWCHART Module 6 GMP Workshop Kuala Lumpur November 2005

9 THE STARTING MATERIALS
Starting materials are very important factors in a cosmetics factory. All the materials going to be used should have been verified and tested compared to an approved specification. Module 6 GMP Workshop Kuala Lumpur November 2005

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MAIN GOALS The main objectives of a cosmetic manufacturer are: to produce finished products from a combination of starting materials to look after all the materials which will influence the quality of finished product compliance with GMP guidelines to avoid product being rejected or recalled from the market. The main objective of a cosmetic factory is to produce finished products from a combination of materials. The way in which the factory is organised to look after all the materials is therefore of vital importance to the quality of the finished product. Special attention must be given to the requirements and guidelines regarding GMP for materials, all stages of production and quality control testing. It includes: Specifying the materials (specifications) Purchasing materials Receiving materials Storing materials Dispensing Using materials for production Storing the finished product Distributing the finished product Dealing with all the reagents and standards used in testing Dealing with the waste materials that arise from the processes. Non-compliance with GMP guidelines could result in manufacturing products not containing the right materials, or the right quality of materials. This is turn can result in products being rejected or recalled from the market. Module 6 GMP Workshop Kuala Lumpur November 2005

11 MATERIAL REQUIREMENTS (1)
All incoming materials should be quarantined immediately after receipt until they are released for use in production Raw materials should be stored under appropriate condition. Storage condition should be controlled, monitored and recorded Quarantine of incoming starting material should be done as soon as they are received at the factory. Sampling for testing purposes should be done according to the standard procedure . Conformed starting materials or finished product are released for used or distribution. Regarding the different characteristics of starting materials , especially raw materials , condition of raw materials storage should be controlled , monitored and recorded. Some specific storage condition are needed for specific raw material ,such as raw materials toxic, flammable , hygroscopic etc. Module 6 GMP Workshop Kuala Lumpur November 2005

12 MATERIAL BASIC REQUIREMENTS (2)
Storage of materials should be orderly to avoid mix up and cross contamination Ensure that there is an effective system in controlling stocks Ensure that consumption of starting materials follows : FIFO ~ First-In-First-Out, or EEFO ~ Earliest Expiry, First Out. Mix up or cross contamination of starting materials can happen if they are not stored in proper and orderly ways . To avoid any error , raw material stock system should be developed which enable controlling the stock and ensure the FIFO and FEFO System are followed. Module 6 GMP Workshop Kuala Lumpur November 2005

13 MATERIAL BASIC REQUIREMENTS (3)
Personnel in charge of raw material purchase should have sufficient knowledge of the materials, products and suppliers of the materials Raw materials should be purchased from qualified suppliers. Raw materials should have approved specification and deliveries are accompanied with a certificate of analysis. it is suggested to purchase raw materials directly from manufacturers or appointed distributors . The purchasing of starting or raw materials is an important activity of the manufacturer. It is not considered as merely an administrative activity. The inspector should ensure that the staff that are responsible for purchasing of materials, have sufficient knowledge of the materials, products and suppliers of the materials. During your inspection, you should also verify that the materials are only bought from the specified suppliers. This is normally specified in the registration dossiers, or approved suppliers list, or specification of the material. To ensure that the correct materials are supplied, manufacturers are advised to rather purchase materials direct from the manufacturer of the material, and, where possible, not from an agent or broker. It is advisable that the manufacturer discusses the specification for the raw materials with the manufacturer. This could ensure that the correct quality of material is supplied to the manufacturer of the finished products. All aspects relating to the production and control of the starting material, including the handling, labelling and packaging requirements can be agreed upon. Aspects relating to complaints and rejection procedures can also be discussed. Du ring your inspection, you will assess how the manufacturer receives materials from the suppliers. The procedure followed (check written SOP against actual procedure), should include checking the consignment for integrity of the containers or package, that the seals are intact, and that the information on the order, delivery note and label on the containers correspond with each other. All containers should be cleaned when necessary before these are taken into the premises, and should be properly labelled with relevant information (e.g. status, name of the material, reference code etc). Module 6 GMP Workshop Kuala Lumpur November 2005

14 MATERIAL VERIFICATIONS
Starting materials should be checked and verified for their conformity to specifications and be traceable to the product. Samples of raw materials should be physically checked for conformity to specifications prior to release for use. Raw materials should be clearly labeled . All materials received should be clean and checked for appropriate protective packing to ensure no leakage, perforation or exposure to environment. Deliveries of raw materials that do not comply with specification should be segregated and disposed according to standard operating procedures Each packing of raw material should be clearly labeled , including the status and can be traced until the finished products where these starting materials are used in the formula . On the arrivals , starting materials should be checked for its conformity, condition of packing , leakage , perforation etc. Unconfirmed or damaged materials should be directly segregated and directly processed for rejection / refusal. Module 6 GMP Workshop Kuala Lumpur November 2005

15 STARTING RAW MATERIALS
KEY CONSIDERATIONS STARTING RAW MATERIALS Capability and responsibility of purchasing personnel Supplier credibility Checking of each consignment Clean and properly labeled outer packing Any damage on the containers Different batches in one consignment Material records and proper documentation Several key issues of starting material management which should be put under consideration: Purchasing Where possible, the factory should ensure that the staff that are responsible for purchasing of materials, have sufficient knowledge of the materials, products and suppliers of the materials. Materials purchaser is expected to have some knowledge on materials , products and suppliers This is not merely a activities of purchase materials with a reasonable prices, but will involve also the level of quality and delivery. Some agreement should be made with the suppliers, regarding the possible rejection , complaint handling etc. Supplier credibility It should be ensured that : the correct quality of material is supplied all aspects relating to the production and control of the starting material, including the handling, labeling and packaging requirements can be agreed upon. aspects relating to complaints and rejection procedures can also be discussed. Consignment Checking the consignment for : integrity of the containers or package, no damaged on seals , corresponding label to the container , cleanliness , relevant information for material handling such as safety aspects etc. seals are intact, information on the order and delivery note label on the containers correspond with each other. Cleaned and Labeled Cleaning of outer packaging of starting materials should be properly Starting materials in the storage area should be properly labeled. The label should bear at least : name and internal reference code batch number(s) given by the supplier manufacturer’s batch or receiving number status of the material (e.g. quarantine, released, rejected, hold) expiry date or re-test date receiving date In cases of computerized system, it should be inspected and and ensure that the system has been validated. Damaged containers Checks the containers for any damage and possible contamination and cross-contamination. Any damage to containers received should be recorded on receipt and reported to the quality control section. Different batches in one consignment Different batches be considered separate for sampling, testing and release. Record and documentation All histories of incoming materials should be recorded Documentation can be done by manual handling or computerized system If used computerized system, should be well validated Module 6 GMP Workshop Kuala Lumpur November 2005

16 STARTING PACKAGING MATERIALS
KEY CONSIDERATIONS STARTING PACKAGING MATERIALS Primary and printed materials control Handling of printed packaging materials Storage and transport to avoid mix-up Issued and returned packaging materials from production area Specific reference number for batch or consignment Checking and recording of packaging component Outdated or obsolete materials Module 6 GMP Workshop Kuala Lumpur November 2005

17 QUALITY OF PACKAGING MATERIALS
The packaging of cosmetic products must provide protection: against all adverse external influences that can alter the properties of the product, e.g. moisture, light, oxygen and temperature variations; against microbial contamination and physical damage; against incorrect information and identification of the product. The kind of packaging materials to be used must: not have any adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption); be stable and product resistant (no change in properties, or affecting its protective function) The final packaging material should be able to protect the product until its intended shelf-life. Module 6 GMP Workshop Kuala Lumpur November 2005

18 LABELS OF INCOMING MATERIALS
Name of Material Internal Code Batch No. Status QUARANTINE Expiry Date Date Received Date Signature Name of Material Internal Code Batch No / Receiving No. Quarantine / Release / Rejected / Hold Status ( Use Color) Sample of starting material labels , which bear some information on it . Color of labels can be different for indicating the status . White indicating “Quarantine “ status , Green for “ Released “ status, and Red for “ Rejected “ status. Yellow for “Hold” status. Retest date , it should be indicated on the label, two or three months before the expiry date to enable to manufacturers make some action in anticipation of rejection. Expiry Date Retest Date Receiving Date Signature Module 6 GMP Workshop Kuala Lumpur November 2005

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SAMPLING LABEL Sampled containers identification A procedure has to be followed for sampling the material. The containers from which samples were taken, should be identified (e.g. a label). Nina 1 of 12 Sample has been taken by QC Sampling of starting materials should be conducted following an approved Standard Operating Procedure ..Containers of starting materials which have been sampled, should be marked by placing a label on it and indicating the total number of containers. After Release status is obtained , Released Label ( Green ) should be put on each container and this label cover the Quarantine Information. Module 6 GMP Workshop Kuala Lumpur November 2005

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REJECTED MATERIALS Clearly marked Rejected materials should be clearly marked as such. Stored separately in off-limits area Access to the area should be controlled. Actions: rejected materials should be returned to the suppliers, destroyed or reprocessed; the action should be described and defined in a procedure; the action to be taken should be approved by authorized personnel; the action and approval must be recorded. Rejected starting materials should handled very carefully to avoid any possibility that it will be used for production. Prevention can be done in the physical aspect as well as administrative one. Physically it can be separated or in a dedicated area for rejection , access to rejection area will be controlled and limited. Rejection of starting material should be followed by a necessary action , following a SOP which have been approved by the authorities. Record should be made on all activities related to Rejection of starting materials. Module 6 GMP Workshop Kuala Lumpur November 2005

21 WASTE MATERIALS HANDLING
All waste materials should be properly handled Should be stored properly and in a safe place Toxic and flammable materials should be stored in a suitable designed, separated and enclosed area Should not be allowed to accumulate Waste materials : Cosmetic manufacturing activities generate a considerable amount of solid , liquid as well as gases waste. Some of them are considered as toxic , irritant, corrosive or toxic. These waste can be originated from every part of manufacturing activities : mixing, washing , filling as well as utility activities. Proper and safe handling of these hazardous waste chemicals are needed , and also its storage while waiting the disposal to the final authorized disposal area . All of these activities should completely comply to the local legislation. Waste materials handling : Proper and safe storage considerable amount of waste, including from laboratories. provision of for proper and safe storage or disposal Toxic and flammable materials toxic and flammable material should be stored in suitable designed , separate , enclosed area comply with the local / country legislation Not allowed to accumulate waste materials regarding the danger caused by these hazardous waste , it should not be accumulated in site / location removals should be made on regulars and frequently based. handling of these activities should strictly follow a Standard Operating Procedure – including its storage . Disposal of these wastes can be only done in a safely manner , and authorized & licensed organization dedicated for this purposes. Module 6 GMP Workshop Kuala Lumpur November 2005

22 MISCELLANEOUS MATERIALS
Other materials maybe present in manufacturing site: Rodenticides, insecticides, sanitizing material used for specific purposes have toxic & hazardous properties Avoid risk of contamination of equipment starting materials Intermediate materials bulk product when these are used or stored on the premises Other than raw materials used for production , there are some other chemicals used for pest control program and cleaning and sanitation program. Most of them are considered as toxic substances and can left some toxic residues on production equipment . Other risk is the possible contamination on intermediate , bulk when they are used or stored on the premises .Its storage should be separated building from the storage of raw materials used for production and access to the storage of these toxic substances should limited only for authorized personnel. Module 6 GMP Workshop Kuala Lumpur November 2005

23 VERIFICATION OF MATERIAL DELIVERY
starting materials should have been tested and passed requirements before these can be delivered to production: - tested according to approved specification bear identification tag based on the status materials should be protected from leakage, contamination, and delivered in good condition containers should be cleaned prior to entry in the production area label should be placed on each weighed material quantity of weighed material is in accordance with the requirement in the written production documents Only released raw materials can be used for production of cosmetic products . Release is based on testing results compared to its specification . This released status should be indicated by a Release label , put on each packing. During preparation of processing, raw materials requested by production should be made by a written requests and should be fulfilled by warehouse Requested raw material will be delivered in a clean and good condition , free from leakage , contamination and .dust Module 6 GMP Workshop Kuala Lumpur November 2005

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PRINCIPLE OF WATER Minimum requirement is drinking-water quality based on national/country standard Systems must be properly maintained to avoid contamination Written/approved specifications and periodic testing are required Monitoring record should be available Refer to ASEAN GMP for Water (attached at hyperlink documents) The principles are contained in the Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World Health Organization, 1999, Annex 5 (WHO Technical Report Series, No. 885). Pharmacopea monographs monographs for water are published in the International Pharmacopoeia, 3rd Edition, Volume 4, 1999, pages WHO, Guidelines for drinking-water quality, 2nd edition, volume 1; WHO, Guidelines for drinking-water quality, 2nd edition, volume 2, WHO, Guidelines for drinking-water quality, 2nd edition, Volume 3; WHO, Guidelines for drinking-water quality, 2nd edition, Addendum to Volume 1; WHO, Guidelines for drinking-water quality, 2nd edition, Addendum to Volume 2. Water must be “potable” before being purified in order to manufacture pharmaceuticals. It must meet minimum WHO purification standards. “Potable” means drinkable, of the quality required for drinking water. The WHO water standard is on the internet at Module 6 GMP Workshop Kuala Lumpur November 2005

25 PRODUCTION PROCEDURES
Module 6 GMP Workshop Kuala Lumpur November 2005

26 BASIC PRODUCTION PRINCIPLES
Starting materials should be tested and approved according its specification Production equipment should be cleaned, safe, appropriate in size, and appropriate for product type to be manufactured Operation on different products should not be carried out simultaneously in the same room, unless there is no potential risk of mix-up and contamination All materials should bear clear labels and batch numbers Limited access in production area, only authorized personnel Handling of materials and products should be based on written instruction/procedure, and where necessary, recorded All work instructions/procedures should be written and approved Batch manufacturing records should be well recorded by qualified and responsible personnel. Note : Basic Principle of Production should be clearly understood before this activities are done. It covers several aspects of production , ranging from starting materials, equipment , premises , methods, procedure, documents etc. Each of this aspect can be described in a more detailed information , as the scope of this principle are quite large. This basic principle can be “ translated “ into practical aspects by a various standard operating procedures . Basic production principles can be described as follow: Starting materials : should be approved according its specification identification and approval label should be appeared on each packing. not yet expired or have been retested each material should has a clear batch / lot no / QC No identity attention on handling of a specific raw materials well packed , no leakage , clean packing. Production equipment : clean condition safe for product & operators appropriate to the size manufactured appropriate to the type of product manufactured. Operations on different product forms should not be carried out simultaneously in the same room unless there is no risk of mix-up or cross-contamination. All materials, bulk containers, major items of equipment, and where appropriate the rooms used should be identified with an indication of the product or material being processed,, and the batch number. Access to production premises should be restricted to authorized personnel. All handling of materials and products, should be done in accordance with written procedures or instructions and, where necessary, recorded. Manufacturing Written Procedure (MP). MP should be made individually based on product, equipment and quantity manufactured. MP prepared jointly by Production and Quality Department MP should be communicated to people concerned. h. Batch Manufacturing Record (BMR). Follow up and checking of activities during manufacturing should be made and recorded. It should be checked and acknowledged by Supervisor. Manufacturing procedure & follow up sheet should be kept in Batch Manufacturing Record Module 6 GMP Workshop Kuala Lumpur November 2005

27 PROCESSING GUIDANCE (1)
There are several guidelines that should be followed prior, during and after each production activities. These are: Area clearance or lines clearance should be done, to avoid mix up of starting materials or finished products In-process and environmental controls should be carried out and recorded. Indication of failure of equipment or services should be monitored and only equipments in good condition should be available in the production area. Cleaning procedures should be written and approved Containers should be cleaned prior to use Any deviation from requirements and expected result should be recorded and investigated prior to start of production and prior to release of the finished product Processing guidance: Work area and equipment are clean and free from any starting materials or other materials not required for the current operation. Any necessary in-process controls and environmental controls should be carried out and recorded. Means should be instituted of indicating failures of equipment or of services (e.g., water, gas) to equipment. Defective equipment should be withdrawn from use until the defect has been rectified. Production equipment should be cleaned according to detailed written procedures and stored only under clean and dry conditions. Containers for filling should be cleaned before filling. Any significant deviation from the expected yield should be recorded and investigated. Any deviation results should be recorded and reported to the supervisor(s) Module 6 GMP Workshop Kuala Lumpur November 2005

28 PROCESSING GUIDANCE (2)
Any significant deviation from the expected yield should be recorded and investigated. Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner. Pipes used for conveying distilled or deionized water should be sanitized according to written procedures Measuring, weighing, recording, and control equipment should be serviced and calibrated at pre-specified intervals and records are maintained. Repair and maintenance operations should not present any hazard to the quality of the products. Processing guidance (cont) : Usage of pipeline system needs some delicate precaution such as correct connection from area to other area , sanitization according to written procedure. Calibration or services of weighing , measuring or control equipment should be done on pre specified interval base . Record of calibration or services should be kept and maintained. All the activities of maintenance, calibration , services should be done in such away which should not present any hazard to the quality of the products. Module 6 GMP Workshop Kuala Lumpur November 2005

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BULK QUARANTINE LABEL ( Company name ) QUARANTINE LABEL Formula Number : Product Name : Manufacturing No : Batch Size : Processing Date : Transfer date & Time : Bulk transferred to : Bulk Valid until : Chemical Microbioogical Sample Finished Product Approval Approval Micro ( ) Yes ( ) No HOLD An example of quarantine label of bulk , put directly on the processing tank during mixing or on the storage tank while waiting the bulk testing result .Some information such as name , batch no etc are indicated on the label. A red mark ( HOLD ) used as indication that the bulk is still under control and not in a single case can be filled. Module 6 GMP Workshop Kuala Lumpur November 2005

30 Both labels should be attached to the BMR
EQUIPMENT LABEL Company Name EQUIPMENT : STATUS Checked and Verified by Date : Valid until Cleaning Status of Equipment CLEANED Company Name : EQUIPMENT STATUS Checked and Verified by Date : Valid until SANITIZED Cleaning Status of Equipment Some sample of labels , indicating the Cleanliness status of equipment . These label should be put or hanged on the equipment / tank and easily seen by the operator . The important think that should be observed is the validity of the status . If the validity is already expired and the equipment are not yet used, it should be re clean / re sanitized. These labels should be attached in the BMR . Both labels should be attached to the BMR Module 6 GMP Workshop Kuala Lumpur November 2005

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PACKAGING GUIDANCE (1) Minimize risk of cross-contamination and mix-ups Different products should not be packaged in close proximity unless there is physical segregation. Line clearance in packaging area should be done. Packaging line should bear the product name and batch number being produced An appropriate procedure should be developed if labeling is delayed to avoid any mix up or mislabeling. Verification of correct performance of printing done separately, checked and recorded. Special care should be taken when cut labels are used and when overprinting is carried out off-line, and in manual packaging operations. Brief guidance during packaging processes : Minimize cross contamination, mix-up, or substtutions It is suggested that different product should not be packaged in close proximity unless there is a physical segregation. The line clearance should be performed according to an appropriate checklist and recorded. It should be assure that the working area , packing lines , printing machines are clean and free from any materials not required for the current operation. Work area, packaging lines, printing machines, and other equipment are clean and free from any materials not required for the current operation. The name and batch number of the product being handled should be displayed at each packaging station or line. If labeling is delayed, appropriate procedures should be applied to ensure that no mix-ups or mislabeling can occur. The correct performance of any printing done separately or in the course of the packaging should be checked and recorded. Special attention should be made when cuts labels are used in the operation and over printing is carried out off line and in hand packing operation. Module 6 GMP Workshop Kuala Lumpur November 2005

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PACKAGING GUIDANCE (2) Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing. On-line control of the product during packaging Samples taken away from the packaging line once opened should not be returned. Return of reworked finished products into the lot can only be done after special inspection, investigation, approval by authorized personnel . Any unusual discrepancy during reconciliation should be investigated before product release Any unused batch-coded materials should be destroyed and recorded. Excess labels and packaging materials should be returned to store; properly tagged/labeled and recorded Brief packaging guidance (cont): Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing. On-line control of the product during packaging should include at least checks on the general appearance of the packages; whether the packages are complete; whether the correct products and packaging materials are used; whether any overprinting is correct; the correct functioning of line monitors. Samples taken away from the packaging line should not be returned. Products that have been involved in an unusual event during packaging should be reintroduced into the process only after special inspection, investigation, and approval by authorized personnel. A detailed record should be kept of this operation. Any significant or unusual discrepancy observed during reconciliation should be investigated before release. Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure should be followed if un coded printed materials are returned to stock. Excess labels and packaging materials should be returned to store and recorded. Any rejected packaging materials should be disposed off accordingly. Module 6 GMP Workshop Kuala Lumpur November 2005

33 WEIGHING & MEASUREMENT
Weighing should be carried out : - in defined areas - using calibrated equipment. All weighing and measurement carried out should be: - recorded - counter checked Detail description and brief weighing and measurement procedures can be found at the hyperlink documents. Weighing activities is a critical point in the production activities. Possibility of errors be frequently happened within this activities . Human errors are the main factor of the case. A preventive measure should be done to avoid any possible error , by creating a written Standard operating procedure of weighing , clear identification of raw materials, routine calibration of weighing equipment , use of clean and dry weighing tools , training of weighing operators etc. Module 6 GMP Workshop Kuala Lumpur November 2005

34 PREVENTION OF CONTAMINATION
Prevention of contamination should be done in every step of manufacturing processes Type of contaminant can vary, starting from dust, gases, vapors, spray, residues from equipment, insect, microbes, or may come from operators clothing. Area where some susceptible products are processed, such as product for babies or products applied around the eye area should be monitored periodically for its microbial content. Cross-contamination should be avoided through proper application of preventive measures Measures to prevent cross-contamination and their effectiveness should be checked periodically . Prevention of contamination should be done in every step of manufacturing processes , it can be happened in the step preparation, weighing , mixing, filling etc. especially for dry product , dissemination of dust during production should be minimized . Detail contamination description can be found at the attached documents, at the end of presentation. Module 6 GMP Workshop Kuala Lumpur November 2005

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IN-PROCESS CONTROL Done within the production area and by production people and/or Quality Control Should be recorded and done as per approved/written SOP Sampling done to verify: physical aspects (weight, volume, amount, etc) text on labels other performance requirements Sampling maybe conducted based on need : during processing activity during packaging (filling & packing) activities : random, sequential, or statistical Samples taken away from the packaging line should not be returned if containers were opened Record of in-process control should be part of the BMR. In process control is an activities conducted during manufacturing , to anticipate the quality level of it finished product . It can be in the form of solubility, pH, microscopic aspect of emulsion etc. For example ,unconformity of bulk during this step can be easily corrected or improved. This activity is normally conducted by production people. Sampling step of the in process control should be indicated in the Standard Operating Procedure . Method of sampling will depend on the need and determined previously . Module 6 GMP Workshop Kuala Lumpur November 2005

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LINE CLEARANCE line clearance should be done prior to processing and filling operations prepare a clearance checklist for each operation material from previous batch should be removed from the line filling machine should be connected to the right outlet of the bulk storage tank number of personnel should be enough to operate the line each personnel has clear understanding of their roles and responsibilities in the processing or filling operation processing line should be clearly identified and labeled with the name of the product and batch number filling lines should be physically identified with the product name, size, batch no, and if needed the destination of products Line or area clearance are done to assure that there will be no mix up of starting material or products during mixing or filling and packing. In general a Checklist is prepared for these activities ,to ensure that there is no point missing. The checking record should be maintained and attached on Batch manufacturing Record. Module 6 GMP Workshop Kuala Lumpur November 2005

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RECONCILIATION Any deviation from the procedures should be avoided as much as possible. If deviations occur, they should be approved in writing by a designated person, with the involvement of the quality control department. Checks on yields and reconciliation of quantities should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits. These are some points to be considered in the reconciliation of the batch: quantity of starting materials, output of finished products, machine efficiency All activities concerning reconciliation should be conducted based on written standard operating procedures. Brief guidance : Reconciliation processes is conducted to verify whether some deviation have been occurs during implementation of mixing or filling / packaging. Any deviation , either in quantity of consumed materials or result of finished product should be verified and investigation report should be made. Approval following a deviation can only be done by a designed person – with the assistance of Quality and Production Department. Theoretical value of reconciliation quantity should be established , for example : 98 % of Finished Product yield , 1 % raw material or packaging loses etc. Reconciliation after bulk processing : quantity of raw material used additional of raw materials, if needed. excess of raw materials actual output compare with standard output man power & machines hours completeness of batch records a written procedure should be established for returning raw materials to warehouse. Reconciliation after filling and packing activities : quantity of packaging material used additional of packaging materials, if needed. excess of packaging materials (good and rejected conditions) disposal of rejected or damage packaging materials batch number on labels, boxes, and outer carton. man power hours machines hours a written SOP should be established for returning packaging materials to warehouse. abc Module 6 GMP Workshop Kuala Lumpur November 2005

38 BATCH NUMBERING SYSTEM (1)
A product identification number/batch number should be assigned to: every finished product every bulk and semi finished product which enables the history of the product to be traced. A batch numbering system should be unique specific for the product non repetitive for the same product Creation of batch number should be based on written guideline (SOP) To facilitate the traceability of a product , a batch numbering system is applied. This batch numbering system should be put on each finished product, bulk and semi finished product .Batch number is specific for a product and non repetitive for the same products . Preferably, batch number will appeared on primary and secondary packaging – minimum on the primary packaging . In general , a batch number indicates the date of manufacturing and sequence of manufacturing, if the product are made on the same days. It can also indicate the country where the products are made or the subcontractor who are making the products. In other cases , the different filling machine can be also indicated on the batch number. Module 6 GMP Workshop Kuala Lumpur November 2005

39 BATCH NUMBERING SYSTEM (2)
The batch number should be printed on: primary packaging secondary packaging (as necessary) A batch number may give information on : date and year of production country, manufacturer or subcontractor sequence of production Records of batch number should be kept and maintained for every finished product until at least 1 year after the expiry date for traceability factor The system on how the batch number is formulated should be written in a Standard Operating Procedures, to enable other people understand the meaning of code used in the bath number system . As other manufacturing documents ,Batch number record should be kept at least one year after expiration date of a product. Module 6 GMP Workshop Kuala Lumpur November 2005

40 HANDLING OF REJECTION OUTPUT
Rejected product should be properly labeled and physically separated Investigation of the root cause of rejection should be done by production and assisted by quality control SOP in handling rejected product should be established, written and approved If rework can be done, written procedure should be prepared by production and approved by quality control Stability of reworked products should be verified and if necessary additional testing should be performed Physical identification of rejected output should be done directly, by putting a rejection label on it. It should be placed separately and if the decision is final, it can be destroyed or other action agreed by the Management, such as reprocess etc. Investigation of rejected output is suggested to be done by Production Department, assisted by Quality Department. Especially for reprocess activities, special requirement should be considered , such as stability of product, additional testing parameters . Module 6 GMP Workshop Kuala Lumpur November 2005

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REPROCESSING Reprocessing is a delicate/tedious activity for a rejected product. There should be a written policy which clearly states that such action is allowed to be done. Reprocessing of rejected product should only be done in exceptional cases. It should only be allowed if the quality of the product is not negatively affected and the product quality still complies with the specifications. It should consider additional testing of reprocessed product, e.g. stability testing of the batch. Complete records should be maintained for reprocessed product A reprocessed product should be given a new batch number. Key issues in reprocessing: It is not a routine activity , and can only be done if the action will not negatively affect final quality of the product and still comply with the specification. Prior to implementation, such action should be evaluated for its risk together by Production and Quality Department. If available, similar case can be used as comparison. Complete record on the action implemented should be maintained and it is suggested that the reprocessed batch should be given a new batch and a link between these two batches should be available. Assessment the SOP to ensure that it clearly describes the manufacturer’s policy and procedure for reprocessing, as well as who will be responsible for evaluating the risks that are involved in reprocessing rejected material. If reprocessing will be done : Additional testing of the reprocessed batch can be done, such as stability test, active ingredient content etc Other possibility than reprocessed the whole batch , small portion can be re processed by mixing this portion. Into the same product , for example : 10 – 20 %. It can be done if the product is frequently made . A standard Operating procedure should be established for treating the reprocess of rejected output. Stability retesting to ensure the self-life of product, if necessary. Proper and complete records should be maintained for reprocessed materials. A reprocessed batch should be given a new batch number. Some manufacturers introduce part or all of a previous batch, into a batch of the same product. Module 6 GMP Workshop Kuala Lumpur November 2005

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DRY PRODUCTS PRODUCTION Module 6 GMP Workshop Kuala Lumpur November 2005

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DRY PRODUCT KEY ISSUES Problem during processing & packaging : cross contamination operators health hazard caused by powder contamination from air, equipment, facilities Recommended preventive measures: use dust collector in weighing area, mixing/blender room and in filling/packaging anti-room with air lock in between central vacuum system is recommended separate closed room apart from wet processing area dedicated personal protective safety equipment for operators more regular health check for operators The main difficulties of manufacturing of dry product are the problem of contamination , whether it is a cross contamination and microbial contamination. Hazard to the operators is also one of the consideration, if the safety protection is not appropriate. Other than personnel, dry product of cosmetic can contaminate the air, building , or equipment etc. Some preventive measures can be recommended to overcome these possible contamination ,by various equipment, separate building , safety protection etc Module 6 GMP Workshop Kuala Lumpur November 2005

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DRY PRODUCT HANDLING Handling of dry materials and products : Weighing room for dry materials should be separated, if necessary For materials used in very small quantity, an equipment with appropriate precision should be used. The room humidity of processing and filling activity should be controlled, when necessary. As additional protection, some precaution can be done such as : separation of weighing room for dry product such as talcum . For color powder , special attention should be given as the weighed quantity is small in quantity and its traces can contaminate other product very easily . It is suggested to use a dedicated tools for weighing color materials – and if possible in a separate weighing area. Some cosmetic product are influence by environmental condition such as humidity , temperature etc. Producing these type of cosmetics, control of humidity and temperature , as well as the level of contaminants ( particles, micro populations ) should be strictly controlled. This type of control can be varied , depend on the capacity and budget of the company. Module 6 GMP Workshop Kuala Lumpur November 2005

45 LOOSE & COMPACT POWDER PRODUCTION
KEY CONSIDERATIONS LOOSE & COMPACT POWDER PRODUCTION Mixing : efficient mixing equipment should be provided dust extraction/collector unit available suitable temperature operator should be in proper uniform with glove and mask Bulk checking : microbial load conforms to specifications particle size and bulk density color homogeneity drop test Filling and packing environmental control; temperature and humidity dust extraction unit operators should follow step by step procedure per written SOP line inspection should be done per approved SOP Each step of Loose and Compact powder manufacturing, Mixing, Bulk Checking and Filling/packing , has different precaution to be made. In the Mixing step , quality of the machine itself should fulfill the requirement needed for the product. Environmental aspect is represented by utilization of dust collector and temperature control , where safety aspect for the operators should be also considered. Parameter of bulk checking should be established in order to guarantee the quality of product , viewed from Application, safety and quality aspects. Due to its characteristics, environmental of the filling room should equipped with dust collector and temperature control. Operators should consider the safety aspects as well as the Standard Operating Procedures dedicated the manufacturing of this kind of product. Module 6 GMP Workshop Kuala Lumpur November 2005

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KEY CONSIDERATIONS EYE SHADOW PRODUCTION Mixing : Same as powder Bulk checking : microbial evaluation should be done as per specification particle size and bulk density color homogeneity bulk density Filling and packing environmental monitoring of the filling room dust extraction/collector unit in the room Temperature and humidity control Friability, hardness and weight test The manufacturing of eye shadow , have similar precaution as those done for Loose and Compact powder regarding the similarity of those two types of products . Slight differences are found in the filling and packing Where some parameters are not found in the loose powder such as friability , hardness etc Module 6 GMP Workshop Kuala Lumpur November 2005

47 SEMI SOLID PRODUCT - LIPSTICK (1)
KEY CONSIDERATIONS SEMI SOLID PRODUCT - LIPSTICK (1) Mixing : the following should be considered protect against over heating during mixing and melting ensure the homogeneity of color care of cross and microbiological contamination Bulk checking : color conformity melting point breaking point, if possible microbiological testing is done randomly Molding, chilling and flaming processes : Color spreading and homogeneity Pay off (adhesiveness on the lips) Texture performance (shiny, smoothness, sharp, etc.) Product weight Prevention during flaming: avoid from the flammable materials use finger gloves Slightly different to Loose and Compact powder , composition of lipstick as well as its application are quite different which resulted different need , handling and control . Overheating of waxes , homogeneity of color ,and possibility of cross contamination are the subject which should be paid attention during mixing. Bulk checking is more viewed toward application of the products , such as color conformity , breaking point etc. During molding, filling and flaming processes , aspects , performance and application are considered factors . Safety and microbiological aspect are done by usage of gloves, avoid flammable materials etc. Module 6 GMP Workshop Kuala Lumpur November 2005

48 SEMI SOLID PRODUCT - LIPSTICK (2)
KEY CONSIDERATIONS SEMI SOLID PRODUCT - LIPSTICK (2) Melting : carefully avoid contamination during melting process. Chilling, flaming & capping: chilling and flaming the lipstick in molds. cleanliness and capping. avoid contamination during process. Molding : pour hot melted lipstick gradually in the mold. Sampling & testing avoid contamination during sampling process. check : Visual appearance, color, odor, breaking point and melting point Key issues during production of lipstick : During melting: Contamination during melting can be avoided by using gloves , clean and appropriate tools , clean environment . During molding: To obtain intended specification, in some cases the molding should be made in gradual ways . In general, batches of lipstick’s bulk are not big enough , i.e kg due to the wide ranges of its colour. During chilling, flaming and capping: Flaming and capping are steps of lipstick production which still conducted in manual ways. To avoid any microbial contamination from the operator’s skin – gloves should be absolutely worn . Clean uniform , hairnet and mask are main requirement . Cleanliness of the environment and equipment are the other main requirements protect lipstick contamination from microbes, including yeast and mold. During sampling and testing: Bulk sampling is one of the microbial contamination due to the un sterile sampling tools. Therefore , sampling devices should be sterilized prior to its utilization . Be remembered, that sterilization period has some expired date (for example 24 hours only ). It should be re sterilized if those tools are not yet utilized . Testing parameters should established prior to manufacturing . Module 6 GMP Workshop Kuala Lumpur November 2005

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WET PRODUCTS PRODUCTION Module 6 GMP Workshop Kuala Lumpur November 2005

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WET PRODUCT HANDLING Liquids, creams and lotions should be produced in such a way as to protect the product from microbial and other contamination. The use of closed systems of production and transfer is recommended. Where pipe-lines are used for delivery of ingredients or bulk products, care should be taken to ensure that the systems are easy to clean. The main difficulties in wet products manufacturing is the problem of contamination, chemical as well as microbial - except for the high content of alcoholic products. It can be overcome by usage of a “ closed system “ Where the contact of wet product to open air is very limited. Unfortunately this system needs a high investment and deep maintenance – so it can not be reached by Small medium enterprises . Problem of cleaning when piping system are installed need to be solved by a very intensive Standard Operating Procedure which need validation and rechecking from time to time. Module 6 GMP Workshop Kuala Lumpur November 2005

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CLOSED SYSTEM PROCESS Closed system closed system can be used for production and transfer of raw and bulk materials high maintenance & cleaning possible leakage & error of connection can be reduced Benefit of closed system : less manpower and faster production leadtime avoid microbial and cross contamination possibility of CIP cleaning safer and higher productivity A closed system of manufacturing has several advantages , such as less contact of products to open air, less manpower , avoid micro and cross contamination , possibility of Cleaning in Place System , give a safer and higher productivity . This closed system can be applied for raw material as well as bulk products. Unfortunately it needs a high investment and intensive maintenance and cleaning. Most of the piping are made of stainless steel materials. Module 6 GMP Workshop Kuala Lumpur November 2005

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PIPING LINES Piping lines consideration : liquid raw materials & bulk transfer consider on quantity losses need intensive cleaning need additional tools : flow meters, pumps clear identification of each piping line avoid too many bending part on piping systems avoid dead end / dead legs on piping easy handling for CIP(Cleaning in Place) verification of cleaning results & sanitization (physical, chemical , microbiological). Before installation of a piping systems in a manufacturing areas for transferring raw materials ,water , bulk Products etc several consideration should be made from the point view of investment , sanitation & hygiene , efficiency in production as well as manpower , possible microbial contamination , cleaning processes , product losses etc. Module 6 GMP Workshop Kuala Lumpur November 2005

53 AEROSOL PRODUCTS PRODUCTION
Module 6 GMP Workshop Kuala Lumpur November 2005

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AEROSOL COMPONENTS Aerosol product components : Gas tight container (metal, glass, plastic, tin plate or aluminum ) Valve closure Actuator button Protective cups Dip tube Operation : discharge of its content by pressure of compressed gas or vapor phase generated by a propellant present in the container as a liquid. Some cosmetics products are in the form of aerosol , such as hair spray, deodorant, perfume etc. Containers of aerosol can commonly be made of metal , glass , tin plate or aluminum . This container is equipped with some devices such as valve closure, actuator button , protective cups and dip tube. This liquid product is discharge by pressure of compressed gas or vapor phase generated by a propellant present in the container as a liquid. The propellant used can be of hydrocarbon gas such as propane ,butane , while CFC’s are not allowed anymore for the environmental reason – damaging the Ozone layers. Module 6 GMP Workshop Kuala Lumpur November 2005

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AEROSOL TYPE Production steps of aerosol : filling of liquid bulk into packing, control of bulk weight closing of packing filling of propellant control of propellant weight final control (density, application, etc ) Types of dispensed aerosol product Inside (content) – two or three phases Outside ( dispensed contents) Product can be dispensed in various forms : Space spray – minute particles, suspended in the air for long time. Surface ( wet spray ) – larger particles Surface spray as jets Foam – gas propellant emulsified with active component of the product. Original unchanged physical form In the manufacturing steps , liquid phase is filled into containers followed by gaseous phase . Each filling should be checked for its weight , before the container is closed. Aerosol products can be dispensed in various form , depend on the size of liquid particles . This liquid content can be in the original form or in the form of foam / emulsion between active component and propellant gas . Module 6 GMP Workshop Kuala Lumpur November 2005

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CORROSION IN AEROSOL Corrosion in aerosol containers: in product and /or pack damage under pressure, accelerated Source of internal corrosion : change of propellant stability in product environment attack by the product electronic interaction of dissimilar metals. water, oxygen and nature of metal in contact with product. Corrosion inhibition and prevention lacquer for internal protection anodizing One aspect that should be verified in the aerosol product, especially product which use metal container is the corrosion problem. This corrosion result can appear in the product itself or can cause a packing damage. This corrosion is accelerated by the fact that the product is under certain pressure . Several factors might be the sources of corrosion such as propellant stability in product , corrosive product , nature of metal , type of metal coating etc. Electro corrosive : corrosion prediction by studying the relation between current and potential applied on the metal containers construction. Some protection against corrosion can be done by coating the inner part of the container ( lacquer ) or make an anodizing process of the metal container . Module 6 GMP Workshop Kuala Lumpur November 2005

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AEROSOL PRODUCTION Specific requirement for aerosol production area : Separate building or location Well ventilated Explosion proof equipment & building Gas detector for flammable propellant Propellant: Distinguishing and essential feature of an aerosol. Liquefied gas propellant: gaseous state in atmospheric pressure and room temperature, but liquefy on compression Chlorofluorocarbon (freon) Hydrocarbon (propane, n-butane , iso-butane) Most of the aerosol products using alcohol as solvent . Regarding the flammable characteristic of alcohol, special precaution should be taken on its safety aspects. Special requirement of manufacturing site are imposed such as : separate building/ location, well ventilated , explosion proof building/ equipment , gas detector for flammable propellant etc. Module 6 GMP Workshop Kuala Lumpur November 2005

58 AEROSOL FILLING PROCESS
Filling of aerosol : cold filling liquid propellant and chilled bulk closed by valve assembly b. under cup filling ambient temperature propellant is injected between valve and can c. pressure filling propellant at room temperature is injected under pressure through the aerosol valve itself. Three different methods of filling can be done in the aerosol manufacturing , which differ in the temperature when the operation is made ,the way how the gas phase is introduced into the container and application of pressure of gas introduction. Module 6 GMP Workshop Kuala Lumpur November 2005

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AEROSOL STORAGE TEST Storage test should take into account : nature of product its application intended market Storage test guidance : full and adequate storage test result obtained after 8 months at 35 °C - 37°C are also favorable for performance over two years at room temperature more rigorous testing required for tropical country. Storage of aerosol product plays an important role on its quality and stability . It should be conducted prior the manufacturing of the products and market destination of the products should be known , as climatic condition can be different from one place to the others especially on its temperature. Module 6 GMP Workshop Kuala Lumpur November 2005

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FINISHED PRODUCTS Outer physical appearance are very important in cosmetic products . Their display in the counter can attract the consumers to buy the products. Module 6 GMP Workshop Kuala Lumpur November 2005

61 FINISHED GOOD PRINCIPLES
While awaiting approval, finished products should be placed & kept under quarantine area at the finished product warehouse. Quarantine label indicates : Date Product name Batch No Quantity Number of pallets As done for starting materials , finished product should be put in quarantine status until the control is finished Checking will be done cy the Quality Department . Quarantine label contains some information of the product should be put on each box / pallet to identify the product. This label indicate at least : date of packing, product name, batch no , quantity . If it is possible, there is a quarantine area to put all the products which are under testing . Module 6 GMP Workshop Kuala Lumpur November 2005

62 FINISHED PRODUCT STATUS
All label concerning with the status of finished products should be shown clearly Quarantine status can be in the form of: physical (rope, racks layers, pallet) computer system Rejected products : identified and physically separated taken out from the stock further process (destruction, reworked, etc) Separation of quarantine areas can be implemented by using a physical means ( robe, rack layers ) or by means of electronic system ( computerized ). Label indicating the status, whether it is in Quarantine, Released or Rejected should be clearly shown . Especially for Rejected Finished product , it should be directly labeled, separated , taken from the stock and follow the further process. A Standard Operating Procedure should be developed for the implementation of the rejection system . Module 6 GMP Workshop Kuala Lumpur November 2005

63 FINISHED PRODUCT STOCK CARD
Some example of Stock card of Finished Products , where it indicates the balance of Incoming and Out coming of Finished Product . Product name and Batch Number should be indicated on this sheet to be used as a traceability Data. Module 6 GMP Workshop Kuala Lumpur November 2005

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RETAINED SAMPLES Some finished products should be taken during the filling , which represent the whole filling. The quantity taken at least is two time quantity needed for a complete analysis of the product . These product is called “ Retained sample “ and kept in dedicated area . The condition of the retained sample room should be similar to the condition of product in the market ( no air condition etc ). These retained sample are used as reference , retesting purposes , stability evaluation studies and evaluation of product complaints. Sample retention program should be carried out for reference and retesting for stability evaluation and in case of product complaint. Module 6 GMP Workshop Kuala Lumpur November 2005

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PRODUCTION DOCUMENTS Before starting the production activities , there are several preparations which can support the production activities, minimize the possibilities of errors , increase the safety aspect , avoid contamination and mix up , and the most important things is : Obtaining a good & high quality product according to the required specification Quality of Finished product are mostly influenced by the situation how good the production preparation are made. Module 6 GMP Workshop Kuala Lumpur November 2005

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PRODUCTION DOCUMENTS Production documents of each cosmetic product should consist of : Master formula Batch manufacturing record ( BMR ) Record of Quality Control Documentation systems are the key factors for achieving a success in manufacturing a cosmetic products. Documentation in production cover many various aspects , from Master Formula until all the compilation of Production and Control documents ( BMR = Batch Manufacturing Records ). These documents also covering Working Order for processing and packaging , Method for processing and packaging . These are the minimum documents of production , which will be kept for certain time ( Expired date + one year ) Module 6 GMP Workshop Kuala Lumpur November 2005

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MASTER FORMULA Master Formula is compilation of all information, related to all aspects involved in the production of a cosmetic products . One Master Formula is applicable only for one type of product Content of a Master Formula :  Master Formula number Product name and product code/number. Issue date & name of the originator History of the Master Formula in case of revision Formula composition, both for raw & packaging material (raw materials should be written by INCI name) List of equipment used Manufacturing procedure, including in-process control with their limit in processing and packaging, where applicable Specification of starting materials, bulk, and finished products Specification of intended packaging materials, and storage condition. Components and assembly method of components in a finished product One Master formula is made only for one type of product , so it is unique. It covers all aspects involved in the Production of a cosmetic products . Master formula is absolutely needed to be used in investigating the “history” of a product and be used as a vital factor in traceability action. Module 6 GMP Workshop Kuala Lumpur November 2005

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MASTER FORMULA Master formula is indicating also the manufacturing method , step by step how the product going to be made. Specification of bulk manufactured , and all necessary additional information is also indicated in this Master Formula sheet. This manufacturing procedure should be prepared in cooperation between Production Department and QA Department. Signature of person in charge from these two Department should appeared on the sheet. Module 6 GMP Workshop Kuala Lumpur November 2005

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PROCESSING WORK ORDER Some written procedures for Processing should be also developed . It contains the type and number of items / raw material requested for production , balance of consumption etc. Record of machine usage and number of man - hour for the operation should be noted and recorded. Reconciliation of bulk manufacturing should be also noted and deviation should be investigated. Module 6 GMP Workshop Kuala Lumpur November 2005

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PACKAGING ORDER Same activities is done for packaging activities. Reconciliation is always noted and calculated. Occupation of machine as well as man hour spent for the filling and packing operation is recorded. Module 6 GMP Workshop Kuala Lumpur November 2005

71 PROCESSING INSTRUCTION
In the Master formula , it is indicated also the activities of Line clearance – to avoid any mix up during filling Operation .Safety aspect is also considered in all the activities of mixing as well as filling and packing. All these activities should be approved by the people who has been given the authority to do the approval. Module 6 GMP Workshop Kuala Lumpur November 2005

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DAILY PACKING REPORT Master formula contains also the Preparation and Method of packaging activities. The most important is the Line Clearance activities. This sheet indicates the type and number of packaging needed for operation and all necessary information related to this activities. Reconciliation is also appear in this sheet , indicating the obtained result . Deviation from the theoretical reconciliation value should be investigated and report should me made before a batch is released. Remaining packaging should be returned to warehouse after correctly counted and Labeled. Return procedure should follow a written standard operating procedure . Damage packaging should also be recorded and included in the counting . Module 6 GMP Workshop Kuala Lumpur November 2005

73 BATCH MANUFACTURING RECORD
Batch Manufacturing Record should be prepared for each batch of product. Each BMR should include the following : Name of product Batch formula Brief manufacturing process Batch or code number Date of the start and finish of processing and packaging Identity of individual major equipment and lines or location used Records of cleaning and sanitation of equipment used for processing as appropriate In-process control and laboratory results, such as pH and temperature test records Packaging line clearance inspection records Any sampling performed during various steps of processing Any investigation of specific failure or discrepancies Results of examinations on packed and labelled products Batch manufacturing Record is a document indicating the “ history “ of one specific batch. It contains all the information needed , suppose one day there will be a complaint of this batch. One BMR is represent only one batch Module 6 GMP Workshop Kuala Lumpur November 2005

74 RELATED HYPERLINK DOCUMENTS
Trainer Manual of Production Reception of Starting Material Flowchart SOP Reception, Storage & Delivery of Starting Materials SOP Sampling of Packaging Material Weighing guidance Supplementary module “Water” SOP for Raw Material Weighing SOP Sampling of Bulk in Process Module 6 GMP Workshop Kuala Lumpur November 2005

75 RELATED HYPERLINK DOCUMENTS
SOP Sampling for Finished Products Personal Protective Equipment Batch Processing Memo Batch Packaging Memo Master Filling Procedure SOP Handling of Product Returned SOP Finished Good Withdrawal Destructive Memo Module 6 GMP Workshop Kuala Lumpur November 2005

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REFERENCES ASEAN Guidelines for Cosmetic GMP (2003) WHO, Basic principle of GMP : Materials WHO GMP: Main Principle for Pharmaceutical Products WHO Technical Series, No 902 : Guidelines on Packaging for Pharmaceutical products, 2002 WHO, Supplementary Training Modules on GMP: Water for Pharmaceutical Use, part 1, 2, and 3 Module 6 GMP Workshop Kuala Lumpur November 2005

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THANK YOU Module 6 GMP Workshop Kuala Lumpur November 2005


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