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What does Good Manufacturing Practice ( GMP ) mean?
This person is not on ResearchGate, or hasn't claimed this research yet. Good Manufacturing Practice (GMP) 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.
When was the GMP added to the ICH work programme?
1994 The EU and the FD A open negotiations on the mutual recognition of GMP inspections. (Agreement was finally reached and a DRAFT was signed. 1998 “GMPs for Starting Materials” is added to the ICH work programme to be decided by an Expert W orking Group. consent before testing it on them (Immel 2005).
Why was the GMP put in place in the US?
Most requirements were put in place as responses to tragic circumstances and to prevent future tragedies. To obtain and maintain GMP compliance, one should know the precedent of the GMP. The present review highlights past, present and future of GMP.
When was GMP added to food, drugs and Cosmetic Act?
1962 The “Thalidomide T ragedy” leads the US Congress to add GMP to the Food, Drugs and Cosmetic Act. and non-penicillin production. 1974 FD A Starts in vestigating some US toxicology laboratories and finds evidence of widespread mis-management and even fraud. damages for “Medicinal Products” with the EU.
Last Update: Oct 2021
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