WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-third report. - World Health Organization; WHO Expert Committee on Specifications for Pharmaceutical Preparations 2008 : Geneva, Switzerland) (Geneva : World Health Organization, 2009)
Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- 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 and risk analysis -- Quality assurance -- distribution and trade of pharmaceuticals -- Quality assurance -- stability -- Prequalifi cation of priority essential medicines and devices -- Prequalifi cation of quality control laboratories -- Prequalifi cation of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Miscellaneous -- Summary and recommendations.
The WHO Expert Committee met in Geneva from October 13-17, 2008.
Keywords: Pharmaceutical Preparations -- standards -- Congresses; Pharmacopoeias as Topic -- Congresses; Reference Standards -- Congresses