WHO Good Distribution Practices for Pharmaceutical Products
History
l October 2005: WHO GDP adopted by
WHO Expert Committee on Specifications for Pharmaceutical Preparations
l November 2006: IMPACT decided to
revise existing GDP to improve security of distribution chain vis-á-vis
counterfeits
l April 2007: IMPACT Regulatory
Implementation Working Group met and identified recommended edits
l September 2007: Proposed revisions
open for comment
l December 2007: Finalized by
IMPACT General Meeting held in Lisbon
l October 2008: Expert Committee
reviewed document and recommended meeting of IMPACT and WHO
l September 2009: Meeting of
Experts
l October 2009: Expert Committee
adopted, pending consideration of outstanding comments
l October 31 2009: General comments
due
l November 2009: Expert Committee
and IMPACT considering final comments
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
l Assist in ensuring the quality and identity of pharmaceutical products
during all aspects of the distribution process.
l Revised to include particular situations and considerations related to
preventing counterfeit medicines from getting into the legitimate supply chain
l 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
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
l 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
l GDP principles should be included in national legislation and guidelines
l Principles apply forward AND backward in the supply chain
l Collaboration between regulators, law enforcement, customs agencies,
manufacturers, distributors, pharmacies,
Highlights
l Regulation: Only authorized
entities should be entitled to buy and sell pharmaceutical products
l Personnel: All personnel should be trained and qualified re: GDP
requirements
l Dispatch: Specifies items to be
included in dispatch notices and procedures
l Repackaging and relabeling: Should be limited
l Recalls: Should be procedures for
prompt recall of known or suspected defective or counterfeit products
Highlights: Traceability
l Shared responsibility across supply chain
l 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
l A suitable and, to the extent possible, internationally compatible
product coding and identification system should be in place
l Traceability vs. Pedigree
Highlights: Counterfeit pharmaceutical products
l Keep suspect counterfeits apart and clearly labeled
l Sale and distribution of suspect counterfeit products should be
suspended and national regulatory authorities notified right away
l 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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