What US 21 CFR Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food requires
US 21 CFR Part 117 implements the FDA Food Safety Modernization Act (FSMA) preventive controls rule for human food. Facilities must conduct a hazard analysis identifying known or reasonably foreseeable biological, chemical, and physical hazards; establish written preventive controls (process, food allergen, sanitation, supply-chain, and recall plan) to significantly minimize or prevent those hazards; monitor, verify, and document the controls; and review records under a Food Safety Plan. The plan must be prepared or overseen by a Preventive Controls Qualified Individual (PCQI). Part 117 also retains the cGMP requirements in Subpart B for personnel, plant, equipment, and process controls.
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-117
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- US 21 CFR Current Good Manufacturing Practice Hazard Analysis and Risk Based Preventive Controls for Human Food
- US 21 CFR § 117.130 Hazard analysis
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