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Author WHO

Title WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-second Report
Published Geneva : World Health Organization, 2008
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Description 1 online resource (150 pages)
Series Technical Report Series, No. 948
Technical Report Series ; No. 948
Contents Preliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifi cations and tests; 4 Quality control International Chemical Reference Substances and International Infrared Reference Spectra; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance new approaches and risk analysis; 8 Quality assurance distribution and trade of pharmaceuticals; 9 Quality assurance stability; 10 Prequalifi cation of priority essential medicines and devices; 11 Prequalifi cation of active pharmaceutical ingredients
12 Prequalifi cation of quality control laboratories13 Active pharmaceutical ingredient master fi le; 14 Regulatory guidance; 15 Nomenclature terminology and databases; 16 Miscellaneous; 17 Summary and recommendations; Acknowledgements; and International Infrared Reference Spectra; condoms for purchase by United Nations agencies; intrauterine devices for purchase by United Nations agencies; Guidelines on active pharmaceutical ingredient mas
Summary The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building process. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph. Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antitubercul
Notes Print version record
Form Electronic book
ISBN 1281744034
9240683100 (electronic bk.)
9781281744036
9789240683105 (electronic bk.)