Quality assurance of pharmaceuticals. WHO guidelines, good practices, related regulatory guidance and GXP training materials, 2016
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 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 75 relevant international guidelines, standards and good practices endorsed by the Committee and reproduced in this volume, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP). This CD-ROM also includes a study pack with a huge set of training materials reflecting the various GXP texts, good practices for manufacturing and quality control.