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WHO Expert Committee on specifications for pharmaceutical preparations : forty-first report.

Material type: TextTextPublication details: Geneva, Switzerland : World Health Organization, c2007Description: iii, 156 pages ; 24 cmISBN:
  • 9789241209434
Subject(s): LOC classification:
  • RS 51 .W67 2007
Contents:
Introduction -- General Policy -- Quality control- specifications and tests -- Quality control- International Reference Materials -- Quality control- national laboratories -- Quality assurance- Good Manufacturing practices -- Quality assurance- inspection -- Quality assurance- distribution and trade related -- Quality assurance- risk analysis -- Quality assurance- Stability -- Prequalification -- Regulatory guidance -- Nomenclature and computerized systems -- Miscellaneous -- Summary and recommendations
Summary: This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier.
Item type: Books
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Holdings
Item type Current library Home library Collection Call number Copy number Status Date due Barcode
Books Books National University - Manila LRC - Main General Circulation Pharmacy GC RS 51 .W67 2007 (Browse shelf(Opens below)) c.1 Available NULIB000009475

Includes bibliographical references.

Introduction -- General Policy -- Quality control- specifications and tests -- Quality control- International Reference Materials -- Quality control- national laboratories -- Quality assurance- Good Manufacturing practices -- Quality assurance- inspection -- Quality assurance- distribution and trade related -- Quality assurance- risk analysis -- Quality assurance- Stability -- Prequalification -- Regulatory guidance -- Nomenclature and computerized systems -- Miscellaneous -- Summary and recommendations

This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier.

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