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WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-third report.

Author: World Health Organization.
Publisher: Geneva : World Health Organization, ©2009.
Series: Technical report series (World Health Organization), 953.
Edition/Format:   Print book : Conference publication : EnglishView all editions and formats
Summary:
The Expert Committee on specifications for pharmaceutical preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the committee through worldwide consultation and an international consensus-building process.
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Genre/Form: Congresses
Additional Physical Format: Online version:
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Geneva : World Health Organization, ©2009
(OCoLC)974992469
Material Type: Conference publication, Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: World Health Organization.
ISBN: 9789241209533 9241209534 9241209488 9789241209489
OCLC Number: 417700376
Notes: The WHO Expert Committee met in Geneva from October 13-17, 2008.
Description: xi, 161 pages ; 24 cm.
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 and risk analysis --
Quality assurance --
distribution and trade of pharmaceuticals --
Quality assurance --
stability --
Prequalifi cation of priority essential medicines and devices --
Prequalifi cation of quality control laboratories --
Prequalifi cation of active pharmaceutical ingredients --
Regulatory guidance --
Nomenclature, terminology and databases --
Miscellaneous --
Summary and recommendations.
Series Title: Technical report series (World Health Organization), 953.

Abstract:

The Expert Committee on specifications for pharmaceutical preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the committee through worldwide consultation and an international consensus-building process.

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