The quality of pharmaceuticals is a continuing concern of the World Health Organization (WHO). The setting of global standards is requested in Article 2 of the WHO Constitution which cites as one of the Organization's functions that it should develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products. To respond to the global need for adequate quality assurnace of pharmaceuticals, WHO Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value.