Transcript 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
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-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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Contents
1. Introduction
12. Dispatch
2. Scope of the document
3. Glossary
13. Transportation and products
in transit
4. General principles
14. Documentation
5. Regulation of the distribution
of pharmaceutical products
15. Repackaging and relabelling
6. Organization and
management
17. Recalls
7. Personnel
19. Counterfeit pharmaceutical
products
8. Quality system
16. Complaints
18. Returned products
9. Premises, warehousing and
storage
20. Importation
10. Vehicles and equipment
22. Self-inspection
11.
Shipment containers and
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container labeling
21. Contract activities
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
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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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