News Item: Good Manufacturing Practice (GMP)
(Category: Misc)
Posted by Ismail
Thursday 02 December 2010 - 21:43:39

GMP = Good Manufacturing Practice, Good Manufacturing Practice, established by the FDA in 1962. This sets out guidelines for quality assurance in production processes of pharmaceuticals, drugs and medical devices. There are many GMP rules with additional and complementary Guidelines:

cGMP (current U.S.)

CGMP (Community EU)

WHO-GMP WHO GMP

PIC-PIC-GMP GMP

GMP GMP legislation laws

Directive 2001/83/EC Article 46 of Directive 2001/83/EC Article 46

Directive 2003/94/EC Directive 2003/94/EC

also included in the AMWHV = drug-producing and drug regulation that is included in the drug-producing = AMWHV and drug regulation

GMP Guidelines GMP Guidelines

EU GMP Guide EU GMP Guide
Annexe 20 (= plants) Annexe 20 (= assets)

GMP - in short,

Goal -> AM, LM, cosmetics produce reliable and reproducible in the desired quality

Apply to:
in all the major manufacturing activities and Hanlungen incurred for the production of AM

Hospitals

the preparation of samples for clinical tests
Animal medicines


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