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GMP

Good Manufacturing Practice
Good Manufacturing Practice (GMP) refers to guidelines for quality assurance of the production processes and environment in the production of pharmaceuticals and active ingredients, but also cosmetics, food and feed.

Quality assurance plays a central role in pharmaceutical manufacturing, as quality deviations can have a direct impact on the health of consumers. A GMP-compliant quality management system gives assurance of the product quality and the fulfilment of the requirements of the health authorities which are prerequisite for marketing. Relevant guidelines for the pharmaceutical sector are developed, for example, through the European Commission, through the Pharmaceutical Inspection Co-Operation Scheme (PIC / S), through the US - American Food and Drug Administration (FDA), as well as, on international level, through the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (previously for active ingredients and quality risk management). The "good manufacturing practice" was introduced by the Food and Drug Administration in 1962 through the current good manufacturing practice (cGMP) initiative.
Glossary Technical terms at a glance

F

Failure Failure Failure Failure criticality Failure effect chain Failure likelihood Failure network Failure severity Failure effect Failure effect severity Failure mode Failure state Fault tree analysis First pass yield FMEA FMEA form FMEA structural analysis FMEA system optimization FMEA analysis FMEA example FMEA moderator FMEA-MSR FMEA-MSR FMEA-MSR

F

FMECA FMEDA Focus element Food and Drug Administration Foundation FMEA Function tree Functional analysis Functional safety management (FSM) Functional structure

G

G8D GAMP GD & T GMP