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