Who Good Distribution Practices for Pharmaceutical Products

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WHO GoodDistributionPractices for

PharmaceuticalProducts

WHO GoodDistributionPractices for

PharmaceuticalProducts

Presented by:

Director of Pharmacy AffairsU.S. Food and Drug Administration


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M ap of

country:


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HistoryHistoryOctober 2005: WHO GDP adopted by WHO Expert Committee on Specifications

for Pharmaceutical PreparationsNovember 2006: IMPACT decided to revise existing GDP to improve security of distribution chain vis--vis counterfeits

April 2007: IMPACT Regulatory Implementation Working Group met andidentified recommended edits

September 2007: Proposed revisions open for commentDecember 2007: Finalized by IMPACT General Meeting held in Lisbon

October 2008: Expert Committee reviewed document and recommendedmeeting of IMPACT and WHO

September 2009: Meeting of Experts

October 2009: Expert Committee adopted, pending consideration of outstandingcomments

October 31 2009: General comments due

November 2009: Expert Committee and IMPACT considering final comments


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C ontentsC ontents

1. Introduction2. Scope of the document3. Glossary4. General principles

5. Regulation of the distributionof pharmaceutical products6. Organization and

management7. Personnel

8. Quality system9. Premises, warehousing and

storage10. Vehicles and equipment

11. Shipment containers andcontainer labeling

12. Dispatch13. Transportation and products

in transit14. Documentation15. Repackaging and relabelling16. Complaints17. Recalls18. Returned products19. Counterfeit pharmaceutical

products20. Importation21. Contract activities22. Self-inspection


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Goals/ScopeGoals/Scope

Assist in ensuring the quality and identity of pharmaceutical products during all aspects of thedistribution process.

Revised to include particular situations andconsiderations related to preventing counterfeit medicinesfrom getting into the legitimate supply chain

Addresses only pharmaceutical products, but may beapplied to medical devices where appropriate Medical device GDPs in early stages of development by trade

organizations


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Definition of distributionDefinition of distribution

The procuring, purchasing, holding, storing,selling, supplying, importing, exporting, or movement of pharmaceutical products, with theexception of the dispensing or providingpharmaceutical products directly to a patient or his or her agent


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General principlesGeneral principles

All parties in distribution chain have a responsibility toensure the quality of the products and that the integrityof the distribution chain is maintained from themanufacturer to the entity responsible for dispensing

GDP principles should be included in nationallegislation and guidelines

Principles apply forward AND backward in the supply

chainCollaboration between regulators, law enforcement,customs agencies, manufacturers, distributors,pharmacies,


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HighlightsHighlights

Regulation: Only authorized entities should be entitledto buy and sell pharmaceutical products

Personnel: All personnel should be trained and

qualified re: GDP requirementsDispatch: Specifies items to be included in dispatchnotices and procedures

Repackaging and relabeling: Should be limitedRecalls: Should be procedures for prompt recall of known or suspected defective or counterfeit products


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Highlights: TraceabilityHighlights: Traceability

Shared responsibility across supply chain

Requirements to have a form of documentation thatcan be used to permit traceability of the products fromthe manufacturer/importer to the entity responsible for dispensing to the patient

A suitable and, to the extent possible, internationallycompatible product coding and identification systemshould be in place

Traceability vs. Pedigree


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Highlights: C ounterfeit pharmaceuticalproducts

Highlights: C ounterfeit pharmaceuticalproducts

K eep suspect counterfeits apart and clearly labeled

Sale and distribution of suspect counterfeit productsshould be suspended and national regulatoryauthorities notified right away

When confirmed as counterfeit, a formal decisionshould be made re: disposal and ensuring that productdoes not re-enter the distribution system


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N ext stepsN ext steps

HOPEFULLY .. It will be finalizedSOO N!!!!


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Q uestions???Q uestions???

Who Good Distribution Practices for Pharmaceutical Products

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