SOP Development Package: Warehousing and Distribution
Regulatory Reference: 21 CFR § 117.93
Development of a documentation and training package to standardize compliance with FDA cGMP requirements for warehousing and distribution, ensuring control over allergen cross-contact, contamination, and food/product deterioration during storage and transport.
Deliverables
1. Program Document
- • Overview of storage and distribution food safety requirements
- • Definitions, objectives, and scope
- • Regulatory context (21 CFR 117.93)
2. Policies
- • Food handling and segregation policy
- • Allergen control during storage and transport
- • Temperature-sensitive goods policy
- • Returned/damaged goods handling
3. Standard Operating Procedures (SOPs)
Includes SOPs on:
- • Receiving, inspection, and storage of food products
- • Pallet storage and segregation (e.g., allergen, hazardous, ready-to-eat)
- • Transport vehicle inspection and loading/unloading protocols
- • Temperature control for perishable goods
- • Emergency procedures for contamination, spills, or cross-contact
4. Forms for Records
- • Receiving log
- • Storage condition verification checklist
- • Vehicle pre-shipment sanitation checklist
- • Temperature monitoring logs
- • Allergen segregation audit form
- • Returned goods log
5. Training Materials
- • Slide deck and handouts: "Safe Warehousing & Transport of Food"
- • SOP walkthrough presentation
- • Staff quiz with answer key
- • Training sign-in sheet and acknowledgment form
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 Warehouse Zone | $150/zone |
| SOP Development – Per Distribution Route/Mode | $175/route |
| Policy Customization (Allergen, Temp-Sensitive) | +$200/each |
| Translation (English to 1 language) | +$300 |
| Annual Review & Update Subscription | +$450/year |
Bundle Package Options
| Bundle Name | Inclusions | Price (USD) |
|---|---|---|
| Storage Essentials Kit | 2 SOPs, 2 forms, 1 policy, basic training module | $700 |
| Warehouse Compliance Bundle | 4 SOPs, 4 forms, 2 policies, training module, 1 allergen add-on | $1,250 |
| Full Distribution Control Bundle | 6 SOPs, 6 forms, 3 policies, full training set, 2 transport modes covered | $1,900 |
| Complete Warehouse & Logistics Suite | 10 SOPs, 10 forms, 5 policies, complete training, 2 custom routes, allergen + temperature control | $2,850 |
Optional add-ons: Remote gap audit, regulatory alignment with FSMA/FSVP/SQF standards, recall readiness module.