What 21 CFR Part 111 - Current Good Manufacturing Practice for Dietary Supplements (FDA) requires
FDA 21 CFR Part 111 sets current good manufacturing practice for persons who manufacture, package, label, or hold dietary supplements, requiring written procedures, personnel hygiene controls, suitable equipment, a production and process control system covering all stages, quality control operations, established specifications, identity and specification testing, master and batch production records, and recordkeeping to ensure each supplement meets its specifications and is packaged and labeled as the master manufacturing record requires.
Pillar: Food & Hospitality · Authority: US Food and Drug Administration (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: 91b9c08308f3285cde1a87703c22a37ba2adfaa13fb4c1b90ac4093733c9a3da
Primary Citations — 10 traced to source
- § 111.1: Who is subject to this part?
- § 111.8: Requirements for written procedures (subpart B).
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