Distribution
Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. It is important that all manufacturing operations are carried out in conformity with the accepted norms of GMP.
The distribution channel and supply chain need to follow quality assurance as well in order that patients are getting quality medicines. WHO has issued a number of international standards assisting Member States and those involved in the supply chain.
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Good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO)
pdf, 116kb
Annex 8, WHO Technical Report Series 961, 2011
Starting materials
- Control and safe trade of starting materials for pharmaceutical products
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Good trade and distribution practices for pharmaceutical starting materials
pdf, 82kb
Annex 2, WHO Technical Report Series 917, 2003 -
WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
pdf, 100kb
Annex 3, WHO Technical Report Series 917, 2003
Finished Products
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Good distribution practices for pharmaceutical products
pdf, 125kb
Annex 5, WHO Technical Report Series 957, 2010 - Certification scheme on the quality of pharmaceutical products moving in international commerce
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Guidelines on import procedures for pharmaceutical products
pdf, 487kb
Annex 12, WHO Technical Series 863, 1996
Procurement
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Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
pdf, 62kb
Annex 6, WHO Technical Report Series 917, 2003 -
Guidelines on the requalification of prequalified dossiers
pdf, 63kb
Annex 6, WHO Technical Report Series 957, 2010 -
Guidelines for the preparation of a procurement agency information file
pdf, 40kb
Annex 7, WHO Technical Report Series 917, 2003 -
A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)
pdf, 435kb
Annex 6, WHO Technical Report Series 937, 2006
Storage
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Guide to good storage practices for pharmaceuticals
pdf, 132kb
Annex 9, WHO Technical Report Series 908, 2003 -
Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization)
pdf, 243kb
Annex 9, WHO Technical Report Series 961, 2011