TY - BOOK TI - WHO Expert Committee on specifications for pharmaceutical preparations: forty-seventh report SN - 9789241209816 AV - RS 189 .W67 2013 PY - 2013/// CY - Geneva, Switzerland PB - World Health Organization KW - DRUG INDUSTRY STANDARDS N1 - 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 N2 - The Expert Committee on Specificatins for Pharmaceutical Preparatins works towards clear, independent and practical standards and guidelines for the quality assurance of medicines ER -