Quality assurance of pharmaceuticals. WHO guidelines, related guidance and GXP training modules, 2014
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, falsified 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. More than 70 relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP). This CD-ROM in addition includes a study pack with a huge set of GXP training materials.