WHO Good Distribution Practices for Pharmaceutical Products

Presented by:

Director of Pharmacy Affairs U.S. Food and Drug Administration

Map of country:

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History
 October 2005: WHO GDP adopted by WHO Expert Committee on Specifications for Pharmaceutical Preparations  November 2006: IMPACT decided to revise existing GDP to improve security of distribution chain vis--vis counterfeits  April 2007: IMPACT Regulatory Implementation Working Group met and identified recommended edits  September 2007: Proposed revisions open for comment  December 2007: Finalized by IMPACT General Meeting held in Lisbon  October 2008: Expert Committee reviewed document and recommended meeting of IMPACT and WHO  September 2009: Meeting of Experts  October 2009: Expert Committee adopted, pending consideration of outstanding comments  October 31 2009: General comments due  November 2009: Expert Committee and IMPACT considering final comments
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Contents
1. Introduction 2. Scope of the document 3. Glossary 4. General principles 5. Regulation of the distribution of pharmaceutical products 6. Organization and management 7. Personnel 8. Quality system 9. Premises, warehousing and storage 10. Vehicles and equipment 11.| Shipment containers and 5 container labeling 12. Dispatch 13. Transportation and products in transit 14. Documentation 15. Repackaging and relabelling 16. Complaints 17. Recalls 18. Returned products 19. Counterfeit pharmaceutical products 20. Importation 21. Contract activities 22. Self-inspection

Goals/Scope
 Assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process.  Revised to include particular situations and considerations related to preventing counterfeit medicines from getting into the legitimate supply chain  Addresses only pharmaceutical products, but may be applied to medical devices where appropriate
Medical device GDPs in early stages of development by trade organizations

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Definition of distribution

The procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical products, with the exception of the dispensing or providing pharmaceutical products directly to a patient or his or her agent

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General principles
 All parties in distribution chain have a responsibility to ensure the quality of the products and that the integrity of the distribution chain is maintained from the manufacturer to the entity responsible for dispensing  GDP principles should be included in national legislation and guidelines  Principles apply forward AND backward in the supply chain  Collaboration between regulators, law enforcement, customs agencies, manufacturers, distributors, pharmacies,
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Highlights
 Regulation: Only authorized entities should be entitled to buy and sell pharmaceutical products  Personnel: All personnel should be trained and qualified re: GDP requirements  Dispatch: Specifies items to be included in dispatch notices and procedures  Repackaging and relabeling: Should be limited  Recalls: Should be procedures for prompt recall of known or suspected defective or counterfeit products
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Highlights: Traceability
 Shared responsibility across supply chain  Requirements to have a form of documentation that can be used to permit traceability of the products from the manufacturer/importer to the entity responsible for dispensing to the patient  A suitable and, to the extent possible, internationally compatible product coding and identification system should be in place  Traceability vs. Pedigree
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Highlights: Counterfeit pharmaceutical products

 Keep suspect counterfeits apart and clearly labeled  Sale and distribution of suspect counterfeit products should be suspended and national regulatory authorities notified right away  When confirmed as counterfeit, a formal decision should be made re: disposal and ensuring that product does not re-enter the distribution system

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Next steps

HOPEFULLY.. It will be finalized SOON!!!!

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Questions???

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