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FDA inspection glossary

Current Good Manufacturing Practice (CGMP)

CGMP is the set of FDA requirements for the methods, facilities and controls used to make drugs. A drug is deemed adulterated if its manufacture doesn't conform to CGMP.

  • Where the rules live. Requirements include 21 CFR parts 210 and 211 for finished pharmaceuticals [1].

Sources

  1. FDA guidance document

See the term in real FDA documents. Your first Form 483 or letter is on us.

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