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- Keywords > Good Distribution Practices (GDP)
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > guidelines and standards
- Keywords > International Pharmacopoeia (The)
- Keywords > international standards - quality of medicines
- Keywords > pharmaceutical quality control
- Keywords > Prequalification of diagnostics, medicines and vaccines - WHO
- Keywords > quality assurance
- Keywords > quality control – specifications and tests
- Keywords > WHO expert committee
(2014; 52 pages)
This booklet provides an overview of guidelines on pharmaceutical quality assurance as adopted by the Expert Committee on Specifications for Pharmaceutical Preparations in recent years.
The Constitution of the World Health Organization (WHO) states that one of the Organization’s primary functions is “to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. WHO provides global standards for pharmaceutical ingredients, good manufacturing practices (GMP), testing of products, regulatory guidelines for authorization of marketing, and correct storage and distribution practices.
Thus, guidelines on the quality assurance of pharmaceuticals are prepared in consultation with the 70-member WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and are then evaluated by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
This brochure aims to give an insight into the Expert Committee’s work by summarizing some of the vital tools for ensuring pharmaceutical quality that were discussed and approved in recent years.