The WHO Expert Committee met in Geneva from October 13-17, 2008.

Includes bibliographical references.

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

Available both in print and online.

U/N 263067

U/N 263068

U/N 263069