What US FDA Preventive Controls for Human Food - 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls Under FSMA requires
21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) is the FDA's implementing regulation for the Preventive Controls for Human Food rule under the FDA Food Safety Modernization Act (FSMA, Public Law 111-353). Part 117 applies to facilities required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FFDCA) that manufacture, process, pack, or hold human food, subject to the §117.5 exemptions including qualified facilities, certain dietary supplements, alcoholic beverages, low-acid canned foods (separately regulated under 21 CFR Part 113), juice (Part 120), seafood (Part 123), warehousing of dairy ingredients pending USDA action, and on-farm activities. Subpart A sets general provisions, including §117.1 (applicability) and §117.3 (definitions). Subpart B sets the cGMP standards for personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment, processes and controls, warehousing and distribution, and defect action levels. Subpart C requires hazard analysis (§117.130), preventive controls (§117.135), validation (§117.160), monitoring (§117.145), corrective actions and corrections (§117.150), verification (§117.155), and a written food safety plan (§117.126). Subpart D requires a written recall plan when a hazard analysis identifies a hazard requiring a preventive control. Subpart E requires supply-chain program for raw materials and other ingredients for which a hazard requiring a supply-chain-applied control has been identified. Subpart F sets recordkeeping including retention for 2 years (or 1 year past the equipment in use date for equipment records).
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-117
SHA-256 integrity: c68c438a26389df05c7b4bebbda200867dc3813b24f65d853d62ca8d1e1beb3f
Primary Citations — 7 traced to source
- FDA Food Safety Modernization Act (FSMA), Public Law 111-353 - statutory basis for the Preventive Controls for Human Food rule
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., including section 415 (registration), section 402 (adulteration), section 418 (hazard analysis and risk-based preventive controls) - statutory authority
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