21 CFR Part 507

This glossary term is part of the SG Systems Global regulatory & operations guide library.

Updated October 2025 • 21 CFR Part 507, Preventive Controls for Animal Food, cGMP, hazard analysis, risk-based preventive controls, supply-chain program, recall plan, records • Primarily animal food (pet food, livestock feed, feed ingredients) with strong overlap to modern food safety system design

21 CFR Part 507 is the U.S. FDA regulation that turns animal food safety into an operational system, not a promise. In plain language: it expects you to manufacture, process, pack, and hold food for animals under baseline GMP / cGMP discipline, and (when applicable) it expects you to identify hazards and run risk-based preventive controls that are actually executed, monitored, verified, and documented.

If you already know 21 CFR Part 117 for human food, Part 507 will feel familiar. The structure is similar, the intent is similar, and the failure modes are painfully similar: weak hazard analysis, “controls” that aren’t measurable, monitoring that isn’t consistent, and records that can’t survive scrutiny when a customer complaint or regulator pressure-tests the story.

Tell it like it is: Part 507 doesn’t reward good intentions. It rewards repeatable control. If your program depends on heroic employees remembering what “should” happen, Part 507 will eventually expose that as a systems problem—because it is.

Part 507 also forces a practical architecture question: do you have a coherent Food Safety Plan (FSP) posture with evidence that is fast to retrieve and hard to dispute? That’s why Part 507 naturally connects to record integrity topics like Data Integrity and Audit Trail (GxP), even in “non-pharma” environments. When your controls are real, your evidence gets easier. When your controls are theater, your evidence becomes improvisation—and regulators are not impressed by improvisation.

“Part 507 isn’t asking you to sound compliant. It’s asking you to operate like you can be audited on your worst day.”

1) What people mean when they cite 21 CFR Part 507

When someone says “we need to comply with Part 507,” they usually mean one of three operational realities—not a vague legal concept.

First: the organization makes animal food (or handles it in a way that matters) and needs a structured food safety posture that can be audited. That means hazards identified, controls defined, monitoring performed, and records available.

Second: the organization had a signal—complaints, pathogen findings, supplier drift, a near-miss, or customer pressure—and leadership wants to stop relying on gut feel. Part 507 is essentially the “make it measurable” regulation.

Third: the organization is growing (more SKUs, more plants, more co-mans, more suppliers). What used to work “because we know our people” stops working when the system must function during turnover, weekends, and exceptions. Part 507 doesn’t care about your company culture. It cares about what you can prove.

If you’re looking for a clean mental model, think of Part 507 as “animal food safety = controlled execution + retrievable evidence.” The evidence is not a paperwork burden; it’s how the regulation detects whether execution is real.

2) Scope map: cGMP vs preventive controls (and why you need both)

A lot of teams get Part 507 wrong because they treat it as “a HACCP plan” or “a GMP checklist.” It is closer to a layered system: baseline GMP discipline plus risk-based controls where hazards require them.

The practical takeaway: cGMP is the floor. Preventive controls are the risk-based layer above it. If you skip the floor, the controls won’t hold. If you skip the risk layer, you’ll miss the hazards that actually cause harm.

3) Who Part 507 applies to (and where teams misclassify themselves)

Part 507 is often mis-scoped because organizations describe themselves by industry label (“pet food brand,” “feed ingredient distributor,” “toll blender”) instead of by function. FDA compliance is function-driven: what you do to the product matters.

In practical terms, Part 507 most commonly matters for:

• Manufacturers and processors of pet food and livestock feed (including thermal processing, blending, extrusion, drying, coating, and packaging).
• Ingredient handlers when holding and handling creates hazard exposure (e.g., storage conditions, segregation, cross-contact, pest risk).
• Operations with complex supplier risk where hazards are controlled upstream and you must prove the control is real.

The most common mistake is claiming “we don’t manufacture” while still performing transformations or critical holding activities. If your operation changes the product, changes its risk profile, or controls (or fails to control) hazards, you are in the game.

4) Hazard analysis: how to make it real (not a brainstorm)

Hazard analysis is where strong programs separate themselves from checkbox programs. A weak hazard analysis is usually a generic template copied from somewhere else. A strong hazard analysis is specific to your ingredients, your processes, your equipment, and your operating reality.

Three patterns make hazard analysis “real”:

1) Tie hazards to entry points. Don’t list hazards in the abstract. Tie them to steps: receiving, storage, batching, thermal processing, cooling, packaging, rework, distribution.

2) Tie decisions to data. If you say a hazard is not reasonably foreseeable, you should be able to explain why without hand-waving. Supplier history, COA trends, environmental results, complaint data, and process capability should influence that decision.

3) Tie controls to measurability. A “control” that can’t be monitored is not a control; it’s a slogan. That’s why mature teams treat hazard analysis as the design input for monitoring and record architecture—not as a document you file away.

If you want a practical operational foundation for the thinking style, HACCP principles are still useful even when your program is formally framed under FSMA preventive controls. The core mindset is the same: identify hazards, control the ones that matter, and prove you did it.

5) Preventive controls: what “control” actually means in execution

The word “control” is abused in food safety programs. In Part 507 terms, a control is something you can define, execute, verify, and document—consistently.

In practice, most preventive controls fall into a small set of categories:

One blunt operational principle: if your preventive control exists only in a SOP paragraph, it is not a preventive control. It is a documentation artifact. Controls must exist in execution.

6) Monitoring, corrections, and corrective actions (the part you can’t hand-wave)

This is the part of Part 507 that hurts teams who live on “we usually do it right.” Monitoring is where you define what gets checked, how often, by whom, and what constitutes a failure. Corrections and corrective actions are where you prove you take failures seriously and prevent recurrence.

Operationally, high-functioning monitoring has three properties:

This is also where record design matters. If monitoring results are trapped in unstructured PDFs or operator notebooks, you will struggle to prove consistent execution—or to learn from your own data.

7) Verification & validation: proving the system works

Verification is how you confirm execution happened as intended. Validation is how you justify that the control is capable of doing what you claim. Teams frequently confuse the two, or they treat both as “QA paperwork.” That’s the wrong mental model.

Verification is operational: review of monitoring records, calibration status checks, pre-op verification, environmental trending, supplier performance checks, and targeted audits.

Validation is scientific/technical: evidence that your process parameters achieve the intended safety outcome (e.g., time/temperature lethality, process capability, or other justification appropriate to the hazard and control design).

Tell it like it is: if you can’t explain why your control should work, you’re betting your compliance (and your customers) on assumption. Part 507 is designed to make assumptions visible.

8) cGMP baseline: the quiet failures that trigger big outcomes

Most real-world failures don’t start with a dramatic “critical limit miss.” They start with baseline discipline decay: sanitation shortcuts, poor segregation, equipment condition drift, pest evidence ignored, moisture control not managed, or rework handled casually. That’s why Part 507 includes cGMP expectations—it’s the part that prevents your operation from creating hazards for free.

A practical way to think about cGMP is: it defines the “normal operating environment” your preventive controls assume. If cGMP is weak, your hazard analysis becomes optimistic fiction.

This is also where teams benefit from treating GMP as a system design problem, not a training problem. The best explanation of the mindset is still: GMP / cGMP is about building operations that can be read back as evidence of control.

9) Supply-chain program: supplier evidence, COAs, and change control

In animal food, a surprising amount of risk lives upstream. If you depend on suppliers to control hazards (micro, chemical, physical, or adulteration risks), your program must govern that dependency. That means you need more than “approved supplier” checkboxes—you need evidence logic.

A mature approach usually includes:

• Clear supplier requirements (specs, test methods, documentation expectations) backed by enforceable governance like Supplier Quality Agreements.
• A COA strategy that is defensible (what attributes you accept on COA, what you verify independently, and how you trend). If you need a clean internal anchor for that concept, use Supplier Verification of COAs.
• Supplier change governance so you’re not blindsided by formula, source, or process changes—see Supplier Change Notifications.

In practice, supply-chain control failures are rarely “we had no idea.” They’re usually “we knew, but the evidence was scattered and the escalation logic was weak.” Part 507 rewards teams who turn supplier management into a controlled workflow with retrievable evidence.

10) Recall readiness: why Part 507 punishes slow truth

Recalls are where your program stops being theoretical. Under stress, the only thing that matters is time-to-truth: what lots are affected, where they went, what controls were executed, and what your disposition authority decided.

A high-functioning recall posture is not “we have a binder.” It’s: (1) you can identify scope quickly, (2) you can stop movement (holds that actually hold), and (3) you can produce complete records without archaeology.

If you want practical implementation patterns that pair well with Part 507 expectations (especially when growth and complexity are real), start with the operational hub approach in Food Safety Management System (FSMS) / HACCP / GFSI Programs, then pressure-test your own retrieval and response discipline using Recall Readiness Software patterns.

11) Records & retention: defensible evidence, not file storage

Part 507 is one of those regulations where “we did it” is meaningless without “here is the record.” But recordkeeping is not the same as saving files. A defensible record has three traits: it’s attributable (who), contemporaneous (when), and complete enough to show what happened and what decision followed.

This is why retention policies matter. A document pile is not a retention system; it’s just entropy with timestamps. If you need a straightforward starting point for governing retention periods, formats, and retrieval expectations, use Record Retention Policy as the anchor—and make sure retention is tied to your event model (receive, test, batch, clean, ship), not just to folders.

And yes: electronic records can be a compliance advantage when they’re designed correctly. The wrong approach is “PDF in a shared drive.” The right approach is structured records with controlled edits, auditability, and fast retrieval aligned to Data Integrity expectations.

12) Where Part 11 thinking intersects animal food records

Part 507 is not “Part 11 for animal food.” But the operational principle behind Part 11—records must be trustworthy, attributable, and protected from silent manipulation—shows up in every serious audit and every serious incident.

Even when teams debate formal applicability, the practical expectation remains: if records are electronic, you need a credible integrity posture. That’s why audit trails, controlled permissions, and meaningful governance matter. It’s not bureaucracy; it’s how you prevent “we can fix it later” from becoming “we can’t prove it at all.”

13) Inspection posture: how FDA pressure-tests your controls

Inspections rarely fail because a company cannot recite the regulation. They fail because the company cannot produce a coherent story from real records. FDA pressure-tests the seams: supplier inputs, rework, changeovers, sanitation verification, exception handling, and training evidence.

If you want to avoid chaos, build a retrieval posture before you need it. The simplest starting point is adopting an audit readiness approach where “proof” is a first-class deliverable, not an afterthought—see Audit Readiness for the practical posture, then adapt it to your animal food risk profile.

Here’s the blunt truth: if your inspection strategy is “we’ll pull it together when asked,” you are gambling. Part 507 is designed to reward organizations that can answer quickly using records produced by normal execution.

14) Common failure patterns: how Part 507 compliance gets faked

• Template hazard analysis. Generic hazards, generic controls, generic monitoring. Looks “complete,” collapses under questioning.
• Controls without measurability. “We control it” with no criteria, no frequency, no failure logic.
• Monitoring after the fact. Numbers entered end-of-shift or end-of-week. That’s reconstruction, not control.
• Supplier dependence without governance. COAs accepted blindly; supplier changes discovered late.
• Records that exist but can’t be retrieved. Evidence scattered across email, shared drives, and tribal knowledge.
• Audit readiness theater. Sprinting to create “packages” during inspections instead of operating in a ready state.

These aren’t minor issues. They are structural. If you see these patterns, the fix is not “more training.” The fix is redesigning how execution produces evidence.

15) Copy/paste readiness scorecard

Use this as a practical self-assessment. If you can’t answer these cleanly, your Part 507 posture is fragile.

The goal is not to score yourself. The goal is to identify where you rely on reconstruction and replace it with event-driven control.

16) How this maps to V5 by SG Systems Global

Part 507 success depends on three system properties: consistent identity, controlled execution, and fast retrieval. That’s why many teams eventually stop treating compliance as “documents” and start treating it as architecture.

V5 supports Part 507 outcomes by making records event-linked and audit-ready rather than reconstructive. In practice, the most relevant building blocks are:
V5 MES for step-linked execution and monitoring capture,
V5 QMS for governed procedures, deviations/CAPA, training, and controlled approvals,
and V5 Connect (API) to pull equipment/ERP signals into a single evidence model instead of scattering them across systems.

The point is not “software solves regulations.” The point is that Part 507 assumes you can prove execution without heroics. Systems either make that normal—or make it painful.

17) Extended FAQ

Q1. Is Part 507 basically “HACCP for animal food”?
Not exactly. HACCP thinking is useful, but Part 507 is broader: baseline cGMP plus risk-based preventive controls (when applicable) with monitoring, verification, and record requirements. The mindset overlaps; the execution expectations are typically more system-driven.

Q2. What’s the most common operational failure under Part 507?
Weak evidence posture. Teams “do the work” but can’t produce consistent, complete records quickly. Under audit or incident pressure, they end up reconstructing—and reconstruction is where errors multiply.

Q3. Can a small operation comply without heavy systems?
Sometimes, if complexity is low and discipline is high. But the moment you scale SKUs, suppliers, shifts, or sites, manual systems become brittle. Part 507 doesn’t punish small businesses; it punishes slow truth and inconsistent execution.

Q4. Where should we start if our program is immature?
Start with scope clarity, then hazard analysis quality, then monitoring design, then retrieval drills. If you can’t retrieve records quickly, you don’t know whether your system is real.

Q5. How do supplier controls fit into Part 507?
If your hazard control depends on a supplier, you need governance that makes that dependency defensible: COA strategy, supplier verification, and supplier change controls that prevent silent risk drift.

Related Reading
If you want to connect Part 507 requirements to execution patterns, use the FSMS / HACCP / GFSI Programs hub as the operational foundation, then tighten supplier evidence using Supplier Quality Agreements and Supplier Change Notifications. For record defensibility, align retrieval and retention to Record Retention Policy and pressure-test yourself with an Audit Readiness posture.