Quality Assurance of Pharmaceuticals, Vol. I

Assurance of the quality, safety and efficacy 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, inadequate pharmaceutical regulation and 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 promote the effective functioning of national regulation and control systems and the application of Internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance on aspects of national drug regulation, product assessment. registration and distribution, The international pharmacopoeia, basic tests for drugs, laboratory services, international trade in pharmaceuticals, counterfeit products and training. Most of the material has been published separately in the Expert Committee’s reports. This compendium brings it together for the first time 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.