WHO Expert Committee on Specifications for Pharmaceutical Preparations
Subtitle: forty-fifth report
Contributors: WHO Expert Committee on Specifications for Pharmaceutical Preparations
Series: WHO Technical report series -- 961; Technical report series (World Health Organization) -- 961.
Publisher: World Health Organization
Published: 2010
Place of publication: Geneva, Switzerland
Language: eng
Number of pages: 428
ISBN-13: 9789241209618
Subjects: Pharmaceutical Preparations; Drug Industry; Drugs; Standards; Specifications; Pharmacopoeias; Quality control; Congresses; Reference Standards; Quality Control; Pharmacopoeias as Topic
Other titles: World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations; Specifications for Pharmaceutical Preparations
Notes: The WHO Expert Committee met in Geneva from October 18-22, 2010.

Includes bibliographical references.

Also available via World Wide Web.
Table of contents: title: Introduction; title: General policy; title: Joint session with the Expert Committee on Biological Standardization; title: Quality control: specifications and tests; title: Quality control: international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra); title: Quality control: national laboratories; title: Quality assurance: good manufacturing practices; title: Quality assurance: new approaches; title: Quality assurance: distribution and trade of pharmaceuticals; title: Prequalification of priority essential medicines; title: Prequalification of quality control laboratories; title: Prequalification of active pharmaceutical ingredients; title: Regulatory guidance; title: Nomenclature, terminology and databases; title: Summary and recommendations; title: Annexes.