What US 21 CFR Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements requires
US 21 CFR Part 111 establishes the cGMP requirements for manufacturers, packagers, labelers, and holders of dietary supplements. Subparts cover personnel, physical plant and grounds, equipment and utensils, production and process controls, identity testing of components prior to use, master manufacturing record (MMR), batch production record (BPR), laboratory operations, manufacturing operations, packaging and labeling, holding and distribution, returned dietary supplements, product complaints, and records. Manufacturers must verify the identity of each component used in the dietary supplement before release of the finished batch.
Pillar: Food & Hospitality · Authority: US FDA · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111
SHA-256 integrity: c65ec815986ec32968d008da5bf545872ecc17d23436c73805424b8ff409ad34
Primary Citations — 5 traced to source
- US 21 CFR Current Good Manufacturing Practice for Dietary Supplements
- US 21 CFR § 111.75 What must you do to determine whether specifications are met
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