Allergen Management Policy for Manufacturers

A written Allergen Management Policy is essential for manufacturers operating in regulated environments. Whether you produce food, supplements, pharmaceuticals, or cosmetics, failing to prevent undeclared allergen cross-contact is a direct violation of global safety standards—including FSMA, GFSI, BRCGS, and ISO 22000.

The FDA consistently ranks undeclared allergens as a top cause of food recalls. And under FSMA, allergen control is no longer optional—it’s enforceable. So, what exactly should your allergen policy include? Who approves it? And how can you ensure it’s actually followed, not just filed away in a binder?

This guide walks through everything manufacturers need to know to create, implement, and enforce a compliance-ready allergen policy—backed by V5 digital enforcement.

“We always had an allergen policy on paper. Now, every element is signed, validated, and tied to production events inside V5.”

— QA Manager, Nutraceutical Manufacturer

Why Allergen Policies Are Mandated by FSMA & GFSI

Under FSMA’s Preventive Controls Rule (21 CFR Part 117), manufacturers must identify allergen hazards and implement controls to minimize or prevent them. This includes:

• Written procedures for ingredient handling and cleaning
• Verification of product labels to match declared allergens
• Training records showing personnel understand allergen risks
• Documented CAPA (Corrective Action Preventive Action) in case of failure

GFSI-benchmarked certifications like BRCGS and SQF also require that allergen management be proactive, documented, and auditable—making your allergen policy a required artifact during any audit or recall investigation.

Core Elements of an Allergen Management Policy

A robust allergen policy outlines exactly how your facility prevents allergen cross-contact. It should be site-specific, risk-based, and clearly reference product SKUs, facility layout, supplier inputs, and employee responsibilities.

• Allergen Risk Assessment – Ingredient mapping, flow charts, and hazard analysis
• Supplier Controls – Certificates of Analysis (COAs), allergen disclosure forms, and approval lists
• Segregation Protocols – Separate storage, labeled containers, and physical barriers
• Cleaning Validation – Swab testing, detergent verification, and documented changeovers
• Labeling Procedures – Verification of declared allergens prior to packaging and release
• Training Documentation – Operator awareness, job-specific SOPs, and re-certification schedules
• Incident Management – Deviation handling, root cause, and escalation into CAPA workflows

These should be supported by version-controlled documents and referenced in your HACCP or HARPC plan. See how this translates into floor-level action: Allergen Control Program – Manufacturing Compliance.

Common Gaps in Allergen Policies (and How to Fix Them)

• Generic policies not tailored to plant layout, SKU profile, or allergens present
• Missing evidence of training or cleaning validation
• No enforcement—the policy exists, but isn’t tied to SOPs or digital checks
• Outdated documents—no revision history or expired approval signatures

V5 helps fix these gaps by embedding allergen control steps directly into batch workflows, enforcing task sequencing, and recording operator sign-offs automatically.

How V5 Digitally Enforces Allergen Management

• Role-based SOP enforcement – Only trained personnel can execute allergen-sensitive steps
• Cleaning verification – Digital prompts and swab results required before next batch
• Label check scanning – Prevents undeclared allergens from entering packaged goods
• CAPA integration – Deviations automatically escalate to QA workflows
• Audit trail – All actions are timestamped and exportable for review

Learn more about how digital allergen control compares with manual logs in: Allergen Control Systems – Manual vs. Digital.

Auditing and Reviewing Your Policy

Your allergen management policy must be approved by site leadership and reviewed annually—or after any allergen-related deviation, complaint, or regulatory audit.

• Schedule annual policy reviews with documented sign-off
• Train staff on changes and validate retention with short quizzes or confirmations
• Use V5 to monitor version history and enforce current SOPs plant-wide

Many companies fail audits not because they don’t have policies—but because they can’t prove those policies are current, reviewed, and enforced.

Industry Examples

• Dry Mixes – Multiple allergens on shared lines require documented sequencing and swabbing
• Supplements – Common risks include soy lecithin, peanut oil, shellfish a_