SOP Development Package: Holding & Distribution of Human Food By-Products for Animal Food
Compliant with 21 CFR §117.95 — CGMP for Animal Food By-Products
This program provides a complete SOP, documentation, and training system to ensure compliance with FDA requirements for handling human food by-products used as animal food under 21 CFR §117.95, ensuring proper container hygiene, contamination prevention, labeling, storage, and transportation controls while aligning with broader animal food requirements under 21 CFR Part 507.
Deliverables
To develop and implement standardized procedures for safe handling, storage, and distribution of food by-products that:
- • Prevent contamination and cross-contact with animal food materials
- • Ensure accurate identification and labeling of by-products
- • Maintain sanitary transport and container conditions
- • Support compliance with FDA CGMP and animal food regulations
- • Provide audit-ready documentation for inspections
Deliverables
1. Program Documentation
- • Overview of regulatory requirements under §117.95
- • Definitions, scope, and responsibilities for handling by-products
- • Alignment with FDA animal food regulations and operational practices
2. Policies
- • Cross-contamination prevention during holding and storage
- • Animal food labeling and identification requirements
- • Transportation, container inspection, and sanitation policies
3. Standard Operating Procedures (SOPs)
- • Handling and storage procedures for food by-products
- • Cleaning and sanitation of containers, drums, totes, and storage areas
- • Inspection and maintenance of bulk transport vehicles
- • Labeling and documentation for animal feed shipments
- • Waste and by-product segregation to prevent contamination
4. Recordkeeping Forms & Logs
- • Container cleaning and sanitation logs
- • By-product identification and labeling records
- • Pre-shipment inspection checklists
- • Holding, transfer, and distribution records
- • Transport container verification forms
5. Training & Competency Materials
- • Training modules on safe handling of food by-products for animal feed
- • SOP walkthroughs and implementation guidance
- • Knowledge assessment quizzes and answer keys
- • Training attendance and acknowledgment records
6. Records Review & Gap Closure
- • Audit checklist to verify required documentation elements and observations
- • Identification and correction of recordkeeping gaps
- • Support for reorganizing records to meet compliance expectations
7. Inspection & Audit Readiness
- • Setup of organized record systems (digital or physical)
- • Procedures to ensure prompt access to records during FDA inspections
- • Documentation aligned with regulatory expectations for review readiness
Optional Program Enhancements
- • Integration with full animal food compliance programs under Part 507
- • CGMP gap assessments for by-product handling operations
- • Multilingual SOPs and training materials
- • Supplier and FSVP coordination for animal food supply chains
- • Advanced inspection readiness and mock audit support
Ideal For
- • Food manufacturers generating by-products used as animal feed
- • Facilities involved in storage, transfer, or distribution of by-products
- • Operations requiring compliance with both human food and animal food regulations
- • Companies preparing for FDA inspections or third-party audits
- • Multi-site operations managing by-product handling and logistics
Program Value
- • Ensures compliance with FDA requirements for animal food by-products
- • Reduces contamination risk during handling and transportation
- • Strengthens traceability and labeling accuracy
- • Provides structured SOPs and documentation for audit readiness
- • Supports integration with broader FSMA and animal food compliance systems
Fees and Subscriptions
Per Unit Pricing
| Service Component | Price (USD) |
|---|---|
| SOP Development – Per Holding Area | $150/area |
| SOP Development – Per Transport Type | $175/type |
| Policy Customization (e.g., Labeling) | +$200/each |
| Translation (English to 1 language) | +$300 |
| Annual Review & Update Subscription | +$450/year |
Bundle Package Options
| Bundle Name | Inclusions | Price (USD) |
|---|---|---|
| By-Product Basics Kit | 2 SOPs, 2 forms, 1 policy, basic training module | $700 |
| Feed-Grade Compliance Bundle | 4 SOPs, 4 forms, 2 policies, training module, 1 labeling add-on | $1,250 |
| Bulk Transport Control Bundle | 6 SOPs, 6 forms, 3 policies, full training set, 2 transport methods covered | $1,900 |
| Full Animal Feed Handling Suite | 10 SOPs, 10 forms, 5 policies, complete training, 2 custom inspections, labeling + sanitation | $2,850 |
Optional add-ons: Remote CGMP gap audit, integration with Part 507 animal food compliance, bilingual staff training module, FSVP coordination support.
