V5 Ultimate
Compliance

21 CFR 507

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals · part 507 · animal food cgmp · fsma animal food · 21 cfr part 507

TL;DR

The animal-food twin of 21 CFR 117 — FSMA's cGMP plus hazard analysis and preventive controls for pet food, livestock feed and rendered ingredients. PCQI required; supply-chain programme for hazards controlled upstream.

21 CFR Part 507 is the FSMA preventive-controls rule for animal food (pet food, livestock feed, treats, and rendered ingredients). Subpart B sets the cGMP for animal-food facilities — personnel, plant and grounds, sanitation, water and ice, equipment, processes and controls, warehousing and distribution, holding and distribution of human-food by-products used for animal food. Subpart C adds hazard analysis and risk-based preventive controls: identify known or reasonably foreseeable hazards (biological, chemical including nutrient deficiencies and toxicities, and physical), evaluate them, and implement process / sanitation / supply-chain / other preventive controls with monitoring, corrective actions, verification, and validation. Subpart E mandates the supply-chain programme for hazards controlled by an upstream supplier.

A Preventive Controls Qualified Individual (PCQI for animal food) must develop or oversee the Food Safety Plan, and the qualified-individual training is distinct from the human-food curriculum. Common 483 themes are inadequate hazard analysis for nutrient toxicities (vitamin D, copper, selenium), missing salmonella controls in dry pet food, and supply-chain programmes that document approval but no verification.

Regulatory anchors
  • 21 CFR Part 507
Industries that live with this
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