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

Author: World Health Organization.
Publisher: Geneva : World Health Organization, ©2008.
Series: Technical report series (World Health Organization), 948.
Edition/Format:   Print book : Conference publication : EnglishView all editions and formats
Summary:
The Expert Committee on Specifications for Pharmaceutical Preparations works towards standards and guidelines for medicines' quality assurance. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph. Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies  Read more...
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Details

Material Type: Conference publication, Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: World Health Organization.
ISBN: 9789241209489 9241209488
OCLC Number: 232115165
Notes: The WHO Expert Committee met in Geneva from October 15-19, 2007.
Description: viii, 138 pages ; 24 cm.
Contents: Introduction --
General policy --
Quality control : specifications and tests --
Quality control : 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 --
Prequalification of priority essential medicines and devices --
Prequalification of quality control laboratories --
Active pharmaceutical ingredient master file --
Regulatory guidance --
Nomenclature, terminology and databases --
Miscellaneous --
Summary and recommendations.
Series Title: Technical report series (World Health Organization), 948.

Abstract:

The Expert Committee on Specifications for Pharmaceutical Preparations works towards standards and guidelines for medicines' quality assurance. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph. Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antituberculosis, antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed. In order to serve the WHO-managed Prequalification Program, two new procedures were adopted, namely on prequalification of intrauterine devices (IUDs) and of male latex condoms, together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines.--Publisher's description.

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