cGMP & HARPC Compliance SOP Templates for Animal Food

Compliance Documentation Based on 21 CFR Part 507 Requirements

To establish foundational compliance with FDA’s current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for animal food, this documentation package provides fully editable SOP templates aligned with 21 CFR Part 507. Designed for animal food manufacturers, co-packers, and distributors, these templates support key quality system functions, feed safety plans, and audit-readiness.

Scope of Work

cGMP & HARPC SOP Template Package

Provide FDA-aligned standard operating procedures (SOPs), policies, and work instructions formatted to 21 CFR Part 507 and delivered as editable Word and PDF files. Templates are suitable for immediate use or customization to internal workflows.

Quality and Safety System SOPs

Develop SOP templates supporting each functional area required under 21 CFR 507:

• Personnel Qualification and Hygiene (Subpart B)
• Facility and Grounds Sanitation (Subpart B)
• Equipment and Utensil Maintenance (Subpart B)
• Plant Operations and Sanitation Controls (Subpart B)
• Preventive Controls for Animal Food (Subpart C)
• Supply Chain Controls (Subpart G)
• Allergen Cross-Contact Prevention (as applicable)
• Recall and Traceability Plans (Subpart C)
• Verification and Validation Procedures (Subpart F)
• Complaint Handling and CAPA Procedures
• Records Management and Retention (Subpart F)

Forms, Checklists, and Support Documents Provide relevant logs, registers, and forms necessary to support implementation of the SOPs, including:

• Cleaning and Sanitation Logs
• Preventive Controls Monitoring Logs
• Process Deviation and Corrective Action Forms
• Supplier Verification Checklists
• Batch Release Records
• Document Control Registers

Training Support (Optional)

Clients may add an optional Training Materials Package that includes training decks, quizzes, acknowledgment forms, and a rollout schedule per SOP section.

Customization Support (Optional)

Client branding, staff role mapping, and workflow terminology can be integrated into the SOPs for an additional one-time customization fee.

Deliverables

SOP Documentation Package

Fully formatted SOPs tailored to 21 CFR Part 507 requirements:

• Provided in both Word and PDF formats
• Each SOP includes document headers, version controls, and cross-reference sections
• Includes a Master SOP Index and Implementation Guide

Forms & Registers

A set of at least 20 support documents including:

• HARPC Plan
• Templates for Animal Food
• Preventive Control Logs
• Sanitation Checklists
• Corrective Action Forms
• Training Records
• Master Document Index

Customization Guide

Instructional guide for internal teams to adapt SOPs to their specific operations, staffing, and production scale.

Fees and Subscriptions

Standard Documentation Package – $1,750.00 (One-Time Fee)

Includes:

• Complete SOP set covering all major 21 CFR 117 requirements
• Forms, logs, and checklists
• Implementation guidance and document control tools

Add-Ons:

• SOP Customization Support: +$300 • Training Materials Package: +$275 • Additional Recordkeeping Forms Bundle: +$225 • Audit Readiness Walkthrough (1-hour Zoom): +$150 • Annual SOP Update Package: +$475/year • Master Binder Setup (digital or print-ready): +$200

Ideal For:

• Animal food manufacturers, feed mills, and pet food processors requiring formal food safety documentation • Facilities preparing for FDA FSMA inspections or third-party certifications (e.g., FAMI-QS, GMP+, SQF Animal Food) • Startups building cGMP and HARPC-compliant programs for commercial feed production • Distributors and co-manufacturers aligning with regulatory or buyer food safety documentation standards