WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-fifth report.
World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations Specifications for Pharmaceutical Preparations
- Geneva, Switzerland : World Health Organization, c2011.
- xii, 428 p. : ill. ; 24 cm.
- WHO Technical report series, 961 0512-3054 ; .
- Technical report series (World Health Organization) ; 961. .
The WHO Expert Committee met in Geneva from October 18-22, 2010.
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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Drugs--Standards--Congresses. Drugs--Specifications--Congresses. Drugs--Quality control--Congresses. Pharmacopoeias--Congresses. Drug Industry--standards--Congresses. Pharmaceutical Preparations--standards--Congresses. Pharmacopoeias as Topic--Congresses. Reference Standards--Congresses. Quality Control--Congresses.