Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
The FSMA rule that modernised US food GMP — it pairs baseline current good manufacturing practice (Subpart B) with a risk-based preventive-controls system (HARPC): a written Food Safety Plan, hazard analysis, and preventive controls with monitoring, corrective actions, and verification. It shifted food safety from reacting to contamination to preventing it.
Facilities that manufacture, process, pack, or hold human food and are required to register with FDA, with exemptions and modified requirements for certain small and low-risk operations.
- 01Prepare a written Food Safety Plan overseen by a Preventive Controls Qualified Individual
- 02Conduct a hazard analysis for biological, chemical (incl. allergens), and physical hazards
- 03Implement preventive controls with monitoring, corrective actions, and verification
- 04Operate a risk-based Supply-Chain Program for supplier-controlled hazards
- 05Maintain cGMP conditions with a focus on allergen cross-contact and sanitation
Finalised in 2015 under the FDA Food Safety Modernization Act (FSMA), superseding the reactive posture of the older Part 110 food GMP with a preventive framework.
21 CFR Part 117: frequently asked questions
Quick answers to common questions about 21 CFR Part 117.
What is 21 CFR Part 117?
21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food — is a regulation issued by the Food and Drug Administration (United States). The FSMA rule that modernised US food GMP — it pairs baseline current good manufacturing practice (Subpart B) with a risk-based preventive-controls system (HARPC): a written Food Safety Plan, hazard analysis, and preventive controls with monitoring, corrective actions, and verification. It shifted food safety from reacting to contamination to preventing it.
Who does 21 CFR Part 117 apply to?
Facilities that manufacture, process, pack, or hold human food and are required to register with FDA, with exemptions and modified requirements for certain small and low-risk operations.
What are the key requirements of 21 CFR Part 117?
FDA 21 CFR Part 117 requires, among other things: Prepare a written Food Safety Plan overseen by a Preventive Controls Qualified Individual; Conduct a hazard analysis for biological, chemical (incl. allergens), and physical hazards; Implement preventive controls with monitoring, corrective actions, and verification; Operate a risk-based Supply-Chain Program for supplier-controlled hazards.
When was 21 CFR Part 117 last updated?
The current version of 21 CFR Part 117 dates from September 2015. Finalised in 2015 under the FDA Food Safety Modernization Act (FSMA), superseding the reactive posture of the older Part 110 food GMP with a preventive framework.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 117 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.