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ASEAN GMP TRAINING MODULE STORAGE

ASEAN GMP TRAINING MODULE STORAGE. Prepared by Harris Lukmanto ~ Indonesia Wan Othman Wan Ismail ~ Malaysia Approved by ASEAN GMP Team Endorsed by ASEAN Cosmetic Committee. CONTENT OF PRESENTATION. Introduction Objective Scope Good Storage Practices General requirements

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ASEAN GMP TRAINING MODULE STORAGE

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  1. ASEAN GMP TRAINING MODULESTORAGE Prepared by Harris Lukmanto ~ Indonesia Wan Othman Wan Ismail ~ Malaysia Approved by ASEAN GMP Team Endorsed by ASEAN Cosmetic Committee Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  2. CONTENT OF PRESENTATION • Introduction • Objective • Scope • Good Storage Practices • General requirements • Premises / warehouse • Storage facilities • Personnel • Stock management and control • Documentation • Supporting explanations • Relevant hyperlink documents • References Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  3. INTRODUCTION Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  4. INTRODUCTION • This module tackles briefly the role of warehouse or storage within the manufacturing and distributor operations. • The current code of practice is being introduced to maintain high quality during storage and distribution of products. Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  5. To gain basic understanding of the Good Storage Practice (GSP) applicable to the warehouse To list the key GSP requirements for storage of the materials or cosmetic products. OBJECTIVES Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  6. The module will cover the storage and distribution of all the materials or cosmetic products SCOPE Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  7. GOOD STORAGE PRACTICES Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  8. DEFINITION OF GSP • The special measures that need to be considered in the storage and distribution of cosmetic product, such that the products will be of the nature and quality intended when it reaches the consumer • Specific procedures for : •  receiving •  storage •  distribution • of materials/cosmetic products Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  9. To ensure that when the end product reaches the consumer, it is of good quality and safe to use. REQUIREMENT OF GSP Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  10. GSP COMPONENTS Premises/warehouse Storage Facilities Personnel Stock management and control Documentation Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  11. PREMISES • General requirement • Size & storage requirements • Temperature and humidity control (where required) • Pest control Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  12. Built for its intended purpose Suitable and approved location Suitable building materials Provide protection Provide security from unauthorized persons Properly maintained GENERAL REQUIREMENTS Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  13. SIZE REQUIREMENT Adequate space provided for all storage activities to prevent mixed up and damage of the materials and products Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  14. Segregated areas required (category) Dedicated areas required (condition) Sampling area Wherever possible sampling area for starting materials should be provided to prevent contamination. STORAGE REQUIREMENT Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  15. Temperature & humidity control (where required) Continuous monitoring of humidity and temperature: Numbers & locations of monitoring points (temperature mapping) Calibrated monitoring equipments Time & frequency of monitoring STORAGE ENVIRONMENT Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  16. STORAGE ENVIRONMENT • Storage temperature requirement should comply with the labeling requirements. • Storage condition must not compromise the safety and quality of the product Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  17. Written pest control program Outsourcing is recommended Use of safe pest control agents No risk of contamination to the materials and products Proper records PEST CONTROL Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  18. STORAGE FACILITIES • General facilities:  sufficient lighting  air-conditioning (where required) • Safety facilities:  personal protective equipments  safety signs  alert/alarm system  fire extinguishers, etc • Forklifts / trolley • Computers • Generators, etc Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  19. PERSONNEL • Qualified personnel with: •  experience •  good health status • Sufficient number of personnel • Appropriate & continuous training programme • Store organization • department heads • supporting staffs •  clerk/store keeper •  storeattendant •  driver/ security guard Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  20. Basic training: e.g.: store / warehouse management, inventory , safety, hygiene, good housekeeping (5 S) Specific training: e.g. computerized stock management Documented procedure Control System TRAINING Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  21. receiving & identity inspection storage & stock control product release, repackaging & transportation product disposal STOCK MANAGEMENT & CONTROL Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  22. All deliveries should be checked: containers are not damaged quantity of deliveries labels suppliers name & address RECEIVING & INSPECTION (1) Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  23. RECEIVING & INSPECTION (2) • product information • product name, batch no • manufacturing/expiry date, • storage requirements: • Stack on pallets • Use standard pallets wooden pallets should be free from pest • Stacking height maximum 1.5 m • Interlocking pattern of the box for stability 1.5 m Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  24. STORAGE & STOCK CONTROL • systematic storage system  sufficient passage way for easy movement  inspection / checking  apply stock card • proper labeling • scheduled stock checkor count Identification labels Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  25. PRODUCT RELEASE • To follow FIFO / FEFO system • Recheck before delivery • Monitor goods condition during transport and at delivery Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  26. RETURNED GOODS Available written procedure: • segregation of returned goods • labeling of returned goods • investigations & evaluations on: quality and safety Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  27. Apply written procedure: segregation of returned goods labeling of returned goods investigations & evaluations on: quality, and safety disposal of goods REJECTED/DAMAGED GOODS Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  28. Written procedure should be established: handling of products before disposal  segregation  labeling disposal method should be according to the company and country regulations regulatory requirements should be always observed PRODUCT DISPOSAL Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  29. General requirements Types of documents Control of documents Record keeping DOCUMENTATION Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  30. Provide clear explanation / instructions: Avoids errors and confusions As a guideline Traceability Regulatory requirements DOCUMENTATION OBJECTIVES Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  31. Procedures proper instruction/explanation of handling an operation/activity that consist of: explanations flowchart charts/photos TYPES OF DOCUMENT (1) Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  32. TYPES OF DOCUMENT (2) • Record • writtenrecords of the operations or activities • type of record; • hard copy; stock cards, logbooks • soft copy Finished Product Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  33. Master Copy Distribution Control Obsolete Copies CONTROL OF DOCUMENT • Master copy • Distribution control • Uncontrolled copies • Retrieval process • Obsolete copies Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  34. Kept in safe place Reviewed/updated from time to time Can be accessed and referred easily Kept within appropriate time Destroy/ dispose according to documented procedure RECORD KEEPING Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  35. Thank You Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  36. SUPPORTING EXPLANATION Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  37. Guidelines : WHO : Annex 9 – Guide to Good Storage Practices for pharmaceuticals, 2003 UK/EU: EC Directive (92/25/EEC) on wholesale distribution UK Guidelines on Good Distribution Practice Australia : Code of Good Wholesaling Practices 1991 GLP INTERNATIONAL STANDARD Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  38. PREMISES BUILT FOR ITS INTENDED PURPOSE • Whenever possible, follow a warehouse layout / construction: • Lay out (drawing) refer to premises module • Ceiling, not compulsory • Adequate ventilation windows to allow air circulation • Protected against flood Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  39. LABELING/ PACKAGING REJECT AREA PACKAGING MATERIALS CARTONS/BOTTLES QUARAN-TINE AREA LABELING/ PACKAGING LABELING/ PACKAGING LABELING/ PACKAGING COMPOUNDING/ FILLING RECEIVING STORAGE WASHING AREA MICRO FILLING FILLING FILLING APPROVED RM QUALITY CONTROL AREA SAMPLING LOCKERS COMPOUNDING COMPOUNDING FEMALE LABEL STORAGE / CODING AREA DISPENSING BATCHING MALE LOCKERS FACTORY LAY OUT STORAGE AREA Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  40. SCREEN LAMP, PROTECTED WITH SCREEN SCREEN VENTILATION CANOPI WEIGHING AREA DOOR PLASTIC CURTAIN Pedestrian mark EXTINGUISHER QUARANTINE REJECTED WAREHOUSE : AN EXAMPLE Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  41. LOCATION & LAYOUT SUITABLE AND APPROVED LOCATION • Location refer to premises • Separated from production / other areas • Should allow a smooth flow, one direction of incoming materials and outgoing finished goods • The storage area should be suitable for receiving, loading, unloading, storing of materials, finished goods according to Good Storage Practice. Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  42. BUILDING MATERIALS • Suitable building materials : • Refer to premises • Storage area/ warehouse is part of the premises of the factory building • Whenever possible,apply appropriate building foundation, concrete floor, brick/solid walls, pile/steel construction, roof-tile or corrugated zinc/aluminum roof. • Provide protection from: • excessive heat & temperature •  sunlight, rain/floods •  dusts & other contaminants •  security from unauthorized persons •  properly maintained, e.g. cleanliness, physical Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  43. PROVIDE PROTECTION Provide protection from: • excessive heat & temperature •  sunlight, rain/floods •  dusts & other contaminants •  security from unauthorized persons •  properly maintained, e.g. cleanliness, physical Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  44. ADEQUATE SPACE • Storage should provide adequate space for activities includes the following: • product receiving & inspection • product storage • product repacking • product distribution •  product disposal Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  45. SEGREGATED AREA Segregated area required for: • Different categories of products, e.g.  starting materials,  hazardous raw materials &  finished goods • Products with different status, e.g.  quarantine,  rejected Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  46. DEDICATED AREA Dedicated areas required for: • Rejected/damaged stock • Returned goods from customers • Recalled goods • “Not for Sale” products Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  47. MONITORING POINTS • Numbers and locations of monitoring points (temperature mapping) : • to ensure a uniform temperature and humidity, at several location in the room a control thermometer and humidity meter is placed and monitor; • to ensure a uniform temperature and humidity at each location, the room could be provided by roof’s ventilation fans to achieve air circulation. Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  48. CALIBRATED MONITOR To ensure a correct and consistent monitoring the thermometer and humidity meter should be calibrated regularly Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  49. MONITORING PERIOD • Time and frequency of monitoring : • This should be determined, usually an hourly period of measurement is appropriate • Suggest day and night measurement because of difference in temperature during that period • The measurement at each monitoring point should be recorded Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  50. STORAGE LIGHTINGS • Guidelines or standard of lightings intensity should be applied according to the activity, i.e.: • Storage 50 – 100 Lux • Laboratory 300 Lux • Processing and filling/packing 500 Lux • Visual examination 1000 Lux Module 10 GMP Workshop Kuala Lumpur 14-16 Nov 2005

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