1 / 76

ASEAN GMP Production Training Module

Comprehensive guide for producing safe cosmetic products following ASEAN GMP standards. Includes raw material handling, production procedures, and quality control measures.

neroe
Download Presentation

ASEAN GMP Production Training Module

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related