4. 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 31 2009: General comments due
November 2009: Expert Committee and IMPACT considering final comments
5. 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. 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. 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. 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. 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. 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. 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
