SOP Development Package: Sanitation of Food-Contact & Non-Food-Contact Surfaces
Compliant with 21 CFR §117.35(d)–(e) — Sanitary Operations (cGMP Requirements)
This program provides a structured sanitation SOP and documentation system to ensure compliance with FDA requirements for cleaning and sanitizing food-contact and non-food-contact surfaces under 21 CFR §117.35, establishing risk-based sanitation controls, cleaning schedules, and verification systems to prevent contamination, cross-contact, and food safety hazards in alignment with the Food Safety Modernization Act (FSMA).
Program Objective
To develop and implement standardized sanitation procedures and controls that:
- • Ensure effective cleaning and sanitizing of food-contact surfaces
- • Maintain hygienic conditions across non-food-contact areas
- • Prevent contamination and allergen cross-contact
- • Establish traceable sanitation records and verification practices
- • Support compliance with FDA cGMP sanitary operations requirements
Scope of Work
Development of customized SOPs and records for:
1. Sanitation of Food-Contact Surfaces
- • Cleaning and sanitizing protocols tailored for:
- ◦ Low-moisture environments
- ◦ Wet processing operations
- • Procedures for:
- ◦ Pre-operational sanitation
- ◦ Post-interruption cleaning
- ◦ Continuous production sanitation
- • Equipment-specific cleaning procedures (e.g., conveyors, blenders, utensils)
2. Sanitation of Non-Food-Contact Surfaces
- • Risk-based cleaning frequencies by area or zone
- • Procedures for maintaining cleanliness of:
- ◦ Walls and floors
- ◦ External equipment surfaces
- ◦ Storage and handling areas
3. Handling of Single-Service Articles
- • Procedures for storage, handling, and disposal
- • Controls to prevent contamination and cross-contact
- • Alignment with hygienic handling practices
Deliverables
- • SOP for cleaning and sanitizing food-contact surfaces (equipment-specific)
- • SOP for non-food-contact surface sanitation (zone-based)
- • SOP for handling and disposal of single-service articles
- • Master cleaning schedule template (customizable by equipment and frequency)
- • Area and zone-based cleaning logs for traceability
- • Training materials, including sanitation guides and visual aids
- • Staff competency quiz and validation tools
- • Internal compliance reference guide aligned with §117.35(d)–(e)
Optional Program Enhancements
- • Additional equipment-specific sanitation SOPs
- • Expanded facility area or zone-based sanitation procedures
- • Customized cleaning schedules based on operational risk levels
- • Training modules and refresher programs for sanitation teams
- • Virtual training sessions and implementation support
- • Annual SOP review and update services
- • Multilingual sanitation documentation and training materials
- • Mock sanitation audits and inspection readiness support
Ideal For
- • Food manufacturers and processors requiring compliant sanitation programs
- • Facilities operating in low-moisture or wet processing environments
- • Operations managing allergen-sensitive production lines
- • Companies preparing for FDA inspections or GFSI-recognized audits
- • Multi-zone facilities requiring structured sanitation controls
Program Value
- • Ensures compliance with FDA sanitary operations requirements
- • Reduces contamination and cross-contact risks
- • Improves consistency and effectiveness of sanitation practices
- • Provides traceable documentation for audit readiness
- • Strengthens overall food safety and hygiene systems
Fees and Subscriptions
Base SOP Package Fee:
Includes templates + 1 food-contact equipment + 1 area → $475
Add-Ons by Scope:
| Item | Description | Price (per unit) |
|---|---|---|
| 🏭 Additional Equipment SOP | Conveyor, slicer, blender, etc. | $125 each |
| 📦 Additional Facility Area SOP | Zone-based (e.g., packaging area, raw material intake, cold room) | $100 each |
| 📊 Custom Cleaning Schedule | Tailored frequency based on risk level and equipment use | $100 |
| 📚 Training Deck + Quiz | Training tools and staff refresher materials | $200 |
| 🧑🏫 Virtual Training Session | 60-minute staff orientation via Zoom | $250 |
Example Pricing Packages
| Package | Inclusions | Total Price |
|---|---|---|
| Starter | Base Package + 2 equipment + 2 areas | $825 |
| Expanded | Base + 5 equipment + 3 areas + Training Deck | $1,350 |
| Comprehensive | Base + 10 equipment + 5 areas + Training + Virtual Session | $2,100 |
Optional Add-Ons
- • Annual SOP Maintenance & Updates – $350/year
- • Translation (Spanish/French/etc.) – $150 per language
- • Mock Sanitation Audit (Virtual, per shift) – $650
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