V5 Ultimate
Compliance

21 CFR 117

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food · preventive controls for human food · pcrh

TL;DR

FSMA's cornerstone food rule — replaces the old 21 CFR 110 cGMP and adds Hazard Analysis & Risk-Based Preventive Controls (HARPC), PCQI, food-defense and supply-chain programmes.

21 CFR Part 117 is the FDA rule implementing FSMA for human food. Subpart B retains and modernises the cGMP (formerly Part 110). Subpart C adds the Preventive Controls — hazard analysis, process / allergen / sanitation / supply-chain preventive controls, recall plan, verification, validation, monitoring, corrective actions, records. Subpart G mandates the supply-chain programme. Subpart D handles the qualified-facility (small-business) modifications.

A PCQI (Preventive Controls Qualified Individual) must oversee the Food Safety Plan. V5's food profile lets the PCQI maintain the Food Safety Plan, link hazards to preventive controls, and capture monitoring/corrective actions/verification with e-signatures.

Regulatory anchors
  • 21 CFR Part 117
How V5 handles it
Food safety — one regulated backbone from HACCP plan to mock recall.
V5's Food Safety stack is purpose-built for food, bakery and supplement plants under FSMA 117, BRCGS, SQF and FDA / EU / UK / Canada / FSANZ labelling. HACCP plan, live CCP monitoring, allergen run-order, glass & brittle plastic register, master sanitation schedule, timed mock recalls, plus bakery-specific operations — bulk silos, sourdough starters, par-baked handoffs, rest & proof timers, country labels with live Nutrition Facts preview, retailer spec versioning with diff, waste-to-feed with allergen-safe gate, and a realtime crew board.
Related terms
PCQIHARPCHACCPFSMA 204SSOPAllergen Control
Want to see 21 CFR 117 in V5?

Free trial, no credit card, onboard in days, not months.

Start freeBook a demo
Back to glossary