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WHO Good Distribution Practices for Pharmaceutical Products. Presented by: Director of Pharmacy Affairs U.S. Food and Drug Administration. Map of country:. History. October 2005: WHO GDP adopted by WHO Expert Committee on Specifications for Pharmaceutical Preparations

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who good distribution practices for pharmaceutical products

WHO Good Distribution Practices for Pharmaceutical Products

Presented by:

Director of Pharmacy Affairs

U.S. Food and Drug Administration

history
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
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
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
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
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
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
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
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
next steps
Next steps

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