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

WHO Good Distribution Practices for

Pharmaceutical Products

WHO Good Distribution Practices for

Pharmaceutical Products

Presented by:

Director of Pharmacy AffairsU.S. Food and Drug Administration

Map of country:

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HistoryHistory 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

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ContentsContents

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

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Goals/ScopeGoals/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

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Definition of distributionDefinition 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 principlesGeneral 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 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: TraceabilityHighlights: 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

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 stepsNext steps

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

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Questions???Questions???