Quality Assurance of Pharmaceuticals, Vol. II

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of high-quality and effective drugs, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharma-ceuticals, WHO’s Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommen-dations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implimentation 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 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 to those working in faculties of pharmacy, in drug regulation and control, and in the pharmaceutical industry.