Series: WHO Technical Report Series. Num Pages: 398 pages, figs, tables. BIC Classification: KNDP; MMG. Category: (P) Professional & Vocational. Dimension: 240 x 160 x 20. Weight in Grams: 815. . 2014. Paperback. . . . . Books ship from the US and Ireland.

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Bibliographic Details

Title: WHO Expert Committee on Specifications for Pharmaceutical Preparations
Publisher: World Health Organization
Publication Date: 2014
Language: English
ISBN 10: 9241209860
ISBN 13: 9789241209861
Binding: Soft cover
Condition: New

About this title

Synopsis

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process.

The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

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