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