cGMP (Current Good Manufacturing Practice)
RegulatoryAlso known as: GMP, Good Manufacturing Practice, 21 CFR Part 111
FDA's mandatory quality standards for supplement manufacturing facilities.
What It Means
Current Good Manufacturing Practice regulations under 21 CFR Part 111 set minimum quality requirements for manufacturing, packaging, labeling, and holding dietary supplements. They cover personnel, plant/grounds, equipment, production/process controls, laboratory operations, and record-keeping. cGMP is a legal obligation for ALL supplement manufacturers — not a voluntary program or achievement.
What It Is Not
cGMP is NOT a certification — it is a legal requirement. Claiming 'cGMP Certified' is misleading because FDA does not issue GMP certificates. Third parties like NSF and NPA offer GMP audit programs, but those are separate from the regulatory requirement itself.
Evidence and References
- regulation21 CFR Part 111 full text
- guidanceFDA cGMP guidance for dietary supplements
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