WHO Expert Committee on specifications for pharmaceutical preparations : forty-seventh report /

WHO Expert Committee on specifications for pharmaceutical preparations : forty-seventh report / World Health Organziation - Geneva, Switzerland : World Health Organization, c2013 - iii, 188 pages ; 24 cm.

Introduction -- General policy -- 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 including active pharmaceutical ingredients -- Prequalification of active pharmaceutical ingredients -- Prequalification of quality control laboratories -- Regulatory guidance -- Nomenclature, terminology and databases -- Miscellaneous -- Summary and recommendations

The Expert Committee on Specificatins for Pharmaceutical Preparatins works towards clear, independent and practical standards and guidelines for the quality assurance of medicines.

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DRUG INDUSTRY STANDARDS

RS 189 .W67 2013