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Quality Assurance of Pharmaceuticals, Volume 2 Update

The second volume of the Compendium on quality assurance of pharmaceuticals has been updated to include all new and revised texts published by WHO through the end of 2003 in the area of good manufacturing practices (GMP), inspection and the use of risk analysis in production of pharmaceuticals. All together it includes 15 different guidance texts which were all adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The texts have been developed, revised and reviewed in a consultative process through participation of members of WHO expert panels, specialists, international professional associations , institutions, international organizations, NGOs and other third parties recognized as being competent in this field.

The texts cover good manufacturing practices and inspection of production sites and distribution channels, as well as the quality system requirements of national GMP inspectorates. The good manufacturing practices include main principles as well as supplementary texts for a number of specific types of products. There are in total six new guidance texts ; two guidelines have been updated.

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