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Promoting GMP implementation: developing training materials for the international audience
Kazushige Morimoto1, Judith Curry, Sabine Kopp
1Strengthening of Pharmaceutical Manufacturing Inspection (SPMI) Project, WHO, Health Technology and Pharmaceuticals, Department of Essential Drugs and Medicines Policy, Quality Assurance and Safety: Medicines, Geneva, Switzerland. morimotok@who.int
Abstract:
This paper outlines the development of a CD-ROM training package entitled: The WHO Basic Training Modules on GMP, intended to support the creation of training courses aimed particularly at government compliance officials who inspect pharmaceutical manufacturing facilities. The material was created over a three-year period in collaboration with a team of external experts, WHO regional and local offices, and Drug Regulatory Authorities of participating countries. The nine training workshops and courses that contributed to the development and evaluation processes were attended by approximately 240 participants from 47 countries. To date over 5,800 copies of the CD-ROM have been distributed.