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

2. Map of country:

4. 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 : General comments due
November 2009: Expert Committee and IMPACT considering final comments

5. 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

6. 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

7. 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

8. 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,

9. 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

10. 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

11. 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

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

13. Questions???