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- 1. 1 GOOD DISTRIBUTION PRACTICE asone of the KEY elements for Quality of Medicinal Products Muhammad Lukmani Ibrahim National Pharmaceutical Control Bureau Ministry of Health Malaysia
- 2. 2 Introduction Distribution Good Distribution Practice(GDP) GDP in Malaysia
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- 4. 4 INTRODUCTION TO THELICENSING ACTIVITIES IN MALAYSIA However , the activities are carried out by the National Pharmaceutical Control Bureau which serves as the Secretariat of the DCA The Control of Drugs & Cosmetics Regulations 1984 empower the Drug Control Authority (DCA), Ministry of Health to implement the Registration of Products and the Licensing of Premises (Manufacturers, Importers , Wholesalers)
- 5. 5 Regulation 7(1) All productsmust be registered & possess appropriate license Regulation 12 (1) Types of licenses (Manufacturer, Import, CTIL, Wholesale) Regulation 12 (4) Validity of license Regulation 13 (1) Processing fees Regulation 14 & 17 The power of authority INTRODUCTION TO THE LICENSING ACTIVITIES IN MALAYSIA
- 6. 1 6 REGULATORY CONCERNS More variety indistribution mode Information on the progress of the transport is not very transparent Counterfeit Special storage needs e.g Temperature sensitivity Origin cannot be confirmed / false origin e.g internet sales NPCB
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- 8. 8 DEFINITION “The division andmovement of pharmaceutical products from the premises of the manufacturer of such products or another central point, to the end user thereof or to an intermediate point by means of various transport methods, via various storage and/or health establishments” WHO (Working Document QAS/08.252, January 2008) DISTRIBUTION
- 9. 9 • Forms animportant activity of the integrated supply chain management of medicinal products. • Various persons and entities are often responsible for the handling, storage and distribution of such product • The quality of medicinal products can be affected by a lack of adequate control over numerous activities which occur during the distribution process • The storage, trade and distribution of medicinal products are activities that are carried out by various companies, institutions and individuals DISTRIBUTION
- 10. 10 Licensed Manufacturer Licensed Manufacturer Licensed Importer Licensed Wholesaler Hospital (Local) Entry Point (Overseas) Pharmacy Clinic Distributionchain in Malaysia (where distribution begins) Repack Distribution Distribution Distribution Distribution Distribution Distribution
- 11. 11 • The natureof the risks involved may generally, however, be the same as those in the manufacturing environment e.g mix-ups, contamination and cross contamination • There are thus aspects in distribution to which the principles of Good Manufacturing Practice (GMP) should be applied • These include, but are not limited to, storage, distribution, transportation, packaging, labeling, documentation and record-keeping practices. GMP VS DISTRIBUTION
- 12. 2 12 Chapter 1 requiressatisfactory arrangements for storage and distribution to maintain quality Chapter 4 requires batch distribution records to be kept Chapter 5 deals with storage after release and the handling of product returned from the market Chapter 8 deals with product complaints and recalls GMP VS DISTRIBUTION Distribution is included within the definition of manufacture in the PIC/S Guidelines
- 13. 13 PRODUCT QUALITY To maintain theoriginal quality, every activity in the distribution of medicinal products should be carried out according to the principles of GMP,GSP and GDP GMP GDP GSP
- 14. 14 GOOD MANUFACTURING PRACTICE GMPis that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification
- 15. 15 GOOD STORAGE PRACTICE Thespecial measures that need to be considered in the storage, transportation and distribution of registered products, such that the registered product will be of the nature and quality intended when it reaches the consumer Guidelines on Good Storage Practice (GSP),2nd Edition, 2004 That part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof WHO (Working Document QAS/08.252, January 2008)
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- 17. 17 Good Distribution Practice(GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorization (MA) or product specification - MHRA, UK - A quality system to ensure that medicinal products are procured, stored, transported, distributed and handled systematically and in an appropriate manner. - HSA, SINGAPORE - GOOD DISTRIBUTION PRACTICE
- 18. 3 18 • To ensurethat the quality of medicinal products are maintained throughout the distribution network Preservation of product quality down supply chain from manufacturer to distributors and eventually to retailers /consumers GDP Quality GDP THE IMPORTANCE OF GDP
- 19. 19 • Traceability To facilitate investigationand effective recall of faulty products THE IMPORTANCE OF GDP
- 20. 20 • Prevention ofthe occurrence of mix-up and cross- contamination • To ensure the correct product is delivered to the correct addressee within a satisfactory time period THE IMPORTANCE OF GDP
- 21. 21 Injectable products werenot stored under the appropriate storage conditions so that their original quality is not affected upon transportation EXAMPLE OF GDP ISSUES Details • Ice packs were placed together with the injectable products during transportation to keep the temperature down. However, the manufacturer failed to prove that the temperature is within the specified storage condition as no temperature monitoring was conducted. Furthermore, temperature indicator was not used during transportation.
- 22. 22 WHO Organization and management Personnel QualityManagement Premises, warehousing and storage Vehicles and equipment Shipment containers and container labelling Distribution Transportation and products in transit Documentation Repackaging and relabelling Complaints Recalls Returned products Counterfeit pharmaceutical products Importation Contract activities Self inspection HSA Personnel Premises and facilities Stock handling and stock control Disposal of products Documentation system Product complaints Product recall Returned material Counterfeit products Self inspection Contract acttivities Handling of API or intermediates EMEA Personnel Documentation Premises and equipment Deliveries to customers Returns Self inspection VARIOUS GDP GUIDELINES
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- 24. 4 24 GDP in Malaysiais currently conducted by adopting the GSP Guidelines (Guidelines on Good Storage Practice (GSP),2nd Edition, 2004 ) PART ONE Personnel Premises and facilities Stock handling and stock control Disposal of pharmaceutical products Documentation PART TWO Product complaints Product recall GDP IN MALAYSIA
- 25. 25 • Working groupon the establishment of GDP Guidelines (incorporating current GSP Guidelines) • Comparison of GDP guidelines that are available PROGRESS .. MALAYSIA
- 26. 26 • No forumfor information exchange • Lack of harmonization of GDP standards • The obsolescence of the respective GDP Guidelines • Control points for transport CHALLENGES TO FACE With regulators
- 27. 27 • Commitment bythe parties involved i.e wholesalers / distributors /transporters • Inadequate understanding and exposure on GDP to the industry • Unwillingness to invest • Counterfeits and adulteration CHALLENGES TO FACE With industries
- 28. 28 1. WHO (WorkingDocument QAS/08.252, January 2008) 2. EMEA, Guidelines on Good Distribution Practice of Medicinal Products for Human Use,1992. 3. HSA, Guidance Notes on Good Distribution Practices,Guide-MQA-013-005,2005 4. Guidelines on Good Storage Practice (GSP),2nd Edition, 2004 REFERENCE
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