Quality Assurance of Pharmaceuticals: A Compendum of Guidelines and Related Materials (Good manufacturing practices and inspection)

2nd Edition. - World Health Organization, 2007. - 414 p. - Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's 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 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 medicines regulation and control, and in the pharmaceutical industry.WHO good manufacturing practices: main principles for pharmaceutical products
WHO good manufacturing practices: starting materials
WHO good manufacturing practices: specific pharmaceutical products
Inspection
Hazard and risk analysis in pharmaceutical products
Sampling operations