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Title WHO Expert Committee on Specifications for Pharmaceutical Preparations [electronic resource] : fortieth report.

Imprint Geneva : World Health Organization, 2006.

Copies

Location Call No. OPAC Message Status
 Axe ProQuest E-Book  Electronic Book    ---  Available
Description x, 461 p. : ill.
Series WHO technical report series ; 937
Technical report series (World Health Organization) ; 937.
Note "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii.
Bibliography Includes bibliographical references.
Summary This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
Reproduction Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
Subject Drugs -- Standards -- Congresses.
Pharmacopoeias -- Congresses.
Drugs -- Quality control -- Congresses.
Genre/Form Electronic books.
Added Author World Health Organization.
WHO Expert Committee on Specifications for Pharmaceutical Preparations (40th : 2005 : Geneva, Switzerland)
ProQuest (Firm)
ISBN 9241209372

 
    
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