WHO Good Distribution Practices for Pharmaceutical Products Presented by: Director of Pharmacy Affairs U.S. Food and Drug Administration

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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-á-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

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 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 GDP’s in early stages of development by trade organizations

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

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,

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

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

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

HOPEFULLY….. It will be finalized SOON!!!! Next steps HOPEFULLY….. It will be finalized SOON!!!!

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