WHO Expert Committee on specializations for pharmaceutical preparations : forty-fifth report
- Geneva : World Health Organization, c2011.
- iii, 428 pages : illustrations ; 24 cm.
- WHO Technical Report Series .
Includes bibliographical references.
Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- Quality control: specifications and tests -- Quality control: international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) -- Quality control: national laboratories -- Quality assurance: good manufacturing practices -- Quality assurance: new approaches -- Quality assurance: distribution and trade of pharmaceuticals -- Prequalification of priority essential medicines -- Prequalification of quality control laboratories -- Prequalification of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Summary and recommendations -- Annexes
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PHARMACEUTICAL PREPARATIONS -- STANDARDS TECHNOLOGY, PHARMACEUTICAL -- STANDARDS DRUG INDUSTRY -- LEGISLATION QUALITY CONTROL