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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
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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