ABSTRACT
The World Health Organization (WHO) provides good manufacturing practice (GMP) guidelines and also offers a program of GMP compliance certification. It is important to know that WHO will offer inspections regardless of the status of marketing authorization applications; most manufacturers will request these inspections in anticipation of participation in the WHO Essential Drugs Program and register as certified suppliers, which will qualify the manufacturer to bid on various WHO-sponsored drug purchase programs. In the drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy,” that is, the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The concepts of quality assurance, GMP, and quality control are interrelated aspects of quality management. They are described in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
