WHO Expert Committee on specifications for pharmaceutical preparations : forty-first report. - Geneva, Switzerland : World Health Organization, c2007 - iii, 156 pages ; 24 cm.

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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DRUGS QUALITY CONTROL

RS 51 .W67 2007