Good Manufacturing Practices课件.ppt

Good Manufacturing Practices By: Carolina Gallango-Brun Sana Khan Vedrana Sahovic 精品文档 The Early Beginnings 1900s house-calls Home remedies, ointments and “miracle elixirs” Entertainment and music No regulations until 1902 Fig. 1. Animation of ancient medicine show 精品文档 Public Involvement 1905 - The Jungle by Upton Sinclair Exposure of unsanitary conditions in meat packing plants Public awareness and involvement Pure Food and Drug Act False labeling became illegal Fig. 2. The Jungle by Upton Sinclair Fig. 3. 1906 Meat processing plant 精品文档 What is GMP? Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods. Fig.4 GMP handbooks for every industry 精品文档 Good Manufacturing Practices Worldwide Enforcement Good Manufacturing Practices are enforced in the United States by the FDA In the United Kingdom by the Medicines and Healthcare Products Regulatory Agency GMPs are enforced in Australia by the Therapeutically Goods Administration In India by the Ministry of Health, multinational and/or foreign enterprises Many underdeveloped countries lack GMPs 精品文档 A Time line of GMP 1902 - Development of the Biologic Control Act 1906 - Development of the Pure Food and Drug Act 1938 - Federal Food, Drug and Cosmetic Act 1941 - Initiation of GMP 1944 - Development of Public Health Services Act 1962 - Kefauver-Harris Drug Amendments released 1963 - Establishment of GMPs for Drugs 1975 - CGMPs for Blood and Components Final Rule 1976 - Medical Device Amendments 1978 - CGMPs for Drugs and Devices 1979 - GLPs Final Rule 1980 - Infant Formula Act is passed 精品文档 1941 Initiation of GMP Sulfathiaziole tablets contaminated with phenobarbital 1941 - 300 people died/injured FDA to enforce and revise manufacturing and quality control requirements 1941 - GMP is born Fig. 5 1906 Certificate