Lack of good manufacturing practices (GMP) has been identified as a major obstacle to the production of locally manufactured medicines of assured quality. In 1998, with financial assistance from the Government of Japan, WHO initiated a project to promote implementation of GMP through development of a set of tools and methods defined to assist countries to improve GMP inspection.
Development of the Basic Training Modules covers Basic Principles of GMP (modules 1 to 14); GMP Inspection Process (modules 15 to 19) and Trainer’s Notes (module 20). The modules were tested during a first pilot training workshop held in China in 1999 attended by inspectors from China, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Nepal, Philippines, and Thailand. A second pilot training workshop was held in South Africa in 2000 and was attended by inspectors from Ethiopia, Ghana, Malawi, Nigeria, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. The resulting modules are now available as a CD-ROM.
WHO Basic Training Modules on GMP. A resource and study pack for trainers, is available from: Quality Assurance and Safety: Medicines, Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland. e-mail: GMP@who.int