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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. CONTENT OF PRESENTATION. Introduction Objectives

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ASEAN GMP TRAINING MODULE PRODUCTION


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    1. ASEAN GMP TRAINING MODULEPRODUCTION • 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 14-16 November 2005

    3. INTRODUCTION Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    4. 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 14-16 November 2005

    5. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    6. 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 14-16 November 2005

    7. Raw material preparation Weighing Bulk storage Processing Delivery to warehouse Filling & packing PRODUCTION MAPPING Production operations must follow clearly defined procedures in accordance with approved specifications, with the objective of obtaining products of desired quality. • 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    8. PRODUCTION FLOWCHART Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    9. THE STARTING MATERIALS Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    10. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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. Module 6 GMP Workshop Kuala Lumpur 14-16 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 . Module 6 GMP Workshop Kuala Lumpur 14-16 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 receivedshould 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    15. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    16. 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 14-16 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 14-16 November 2005

    18. LABELS OF INCOMING MATERIALS Name of Material Internal Code Batch No. QUARANTINE Status Expiry Date Date Received Date Signature Name of Material Internal Code Batch No / Receiving No. Quarantine / Release / Rejected / Hold Status ( Use Color) Expiry Date Retest Date Receiving Date Signature Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    19. 1 of 12 Sample has been taken by QC Nina 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). Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    20. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    24. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    25. PRODUCTION PROCEDURES Module 6 GMP Workshop Kuala Lumpur 14-16 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. Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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 hazardto the quality of the products. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    29. ( 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 BULK QUARANTINE LABEL Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    30. Cleaning Status of Equipment Cleaning Status of Equipment Company Name Company Name : EQUIPMENT : EQUIPMENT : STATUS : STATUS : SANITIZED CLEANED Checked and Verified by : Date : Checked and Verified by : Date : Valid until : Valid until : EQUIPMENT LABEL Both labels should be attached to the BMR Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    31. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    32. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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 - counterchecked Module 6 GMP Workshop Kuala Lumpur 14-16 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 . Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    35. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    36. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    37. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 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 • nonrepetitive for the same product • Creation of batch number should be based on written guideline (SOP) Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    41. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    42. DRY PRODUCTS PRODUCTION Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    43. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    44. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    45. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    46. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    47. 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 Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    48. Chilling, flaming & capping: • chilling and flaming the lipstick in molds. • cleanliness and capping. • avoid contamination during process. Melting : carefully avoid contamination during melting 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 CONSIDERATIONS SEMI SOLID PRODUCT -LIPSTICK (2) Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    49. WET PRODUCTS PRODUCTION Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005

    50. 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. Module 6 GMP Workshop Kuala Lumpur 14-16 November 2005