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

RS 51 .W67 2011