FDA cGMP Requirements for Food Manufacturers in 2026

Assurentry Team · February 2026

Overview of 21 CFR 117

FDA's Current Good Manufacturing Practice (cGMP) requirements for human food are codified in 21 CFR Part 117. All facilities that manufacture, process, pack, or hold human food must comply with Subpart B (general provisions). Facilities above certain size thresholds also need preventive controls under Subparts C and G.

Subpart B: Personnel, Plant, and Sanitation

Requirements include: trained personnel with adequate hygiene, plant design to prevent contamination, sanitation procedures, allergen controls, and supplier verification. See HACCP vs. preventive controls for how these fit together.

Preventive Controls for Qualified Facilities

Most food facilities must implement a Food Safety Plan with hazard analysis, preventive controls, monitoring, corrective actions, and verification. Qualified facilities may use a modified approach. Qualified individuals must prepare and oversee the plan.

Recordkeeping and Inspections

Records related to cGMP and preventive controls must be maintained and made available to FDA upon request. Biennial registration renewal ties into facility compliance—see food facility renewal for deadlines.

2026 Considerations

FDA continues to inspect for cGMP and preventive control compliance. Ensure your Food Safety Plan is current, personnel are trained, and records are inspection-ready.