SOP Development Package: Holding and Distribution of Human Food By-Products for Use as Animal Food
Regulatory Reference: 21 CFR § 117.95
Development of a documentation and training package to standardize compliance with FDA CGMP requirements for holding and distributing food by-products for animal feed, ensuring proper container hygiene, contamination prevention, accurate labeling, and safe transportation in accordance with 21 CFR §117.95.
Deliverables
1. Program Document
- • Overview of §117.95 animal feed by-product controls
- • Definitions, compliance scope, and responsibilities
- • FDA regulatory context and alignment to Part 507
2. Policies
- • Cross-contamination prevention policy during by-product holding
- • Animal food labeling and identification policy
- • Transportation and container inspection policy
3. Standard Operating Procedures (SOPs)
Includes SOPs on:
- • Handling and storage of human food by-products
- • Cleaning and sanitation of containers, drums, and totes
- • Inspection and maintenance of bulk transport vehicles
- • Labeling and documentation for animal feed shipments
- • Trash and waste segregation near animal food products
4. Forms for Records
- • Container cleaning log
- • By-product identification & labeling log
- • Pre-shipment inspection checklist
- • Holding & transfer records for by-products
- • Transport container verification form
5. Training Materials
- • Slide deck and handouts: “Safe Handling of Food By-Products for Animal Feed”
- • SOP walkthrough guide
- • Staff quiz with answer key
- • Training attendance log and acknowledgment sheet
6. Records Review & Gap Closure
- • Audit checklist to assess if records contain values/observations as required under §117.305(b)
- • Support for supplementing or reorganizing existing records under §117.330
7. Official Review Readiness
- • Binder/drive setup for physical or electronic record retrieval
- • Procedures to support §117.320 prompt availability for FDA inspections
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.