21 CFR 111
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · dietary supplements cgmp · 111
The FDA cGMP for dietary supplements — identity testing on every incoming component, MMR/BPR, quality unit sign-off on every batch.
21 CFR Part 111 is the cGMP for dietary supplements. Notable demands: §111.70 identity testing on every incoming component, §111.205 MMR, §111.255 BPR, §111.103 quality-unit independence and authority, §111.135 release-by-quality-unit, §111.260 product-complaint files.
A Part 111 inspection focuses heavily on identity testing (the single most-cited 483) and on MMR/BPR completeness. V5's supplements profile enforces identity test before kiosk dispense, generates MMR-snapshotted BPRs, and tracks complaints through to CAPA.
- 21 CFR Part 111
Free trial, no credit card, onboard in days, not months.