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WHO Expert Committee on specializations for pharmaceutical preparations : forty-fifth report.

Material type: TextTextPublication details: Geneva, Switzerland : World Health Organization, c2011Description: iii, 428 pages : illustrations ; 24 cmISBN:
  • 9789241209618
Subject(s): LOC classification:
  • RS 51 .W67 2011
Contents:
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
Item type: Books
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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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