SOP Development Package: Food Processing Operations & Raw Material Control

Compliant with 21 CFR §117.80 — Processes and Controls (CGMP Requirements)

This program provides a structured SOP and recordkeeping system to ensure compliance with 21 CFR §117.80, focusing on controlling manufacturing, processing, packing, holding, and raw material handling activities to prevent contamination, adulteration, and food safety risks, while establishing standardized operational controls, sanitation procedures, and quality assurance protocols aligned with the Food Safety Modernization Act (FSMA).

Program Objective

To develop and implement comprehensive SOPs and operational controls that:

• Ensure safe and sanitary food processing operations
• Establish control over raw materials and ingredients
• Prevent contamination, cross-contact, and adulteration
• Support compliance with CGMP and FSMA requirements
• Provide audit-ready documentation for FDA inspections

Scope of Work

A. Manufacturing, Processing, Packing & Holding Operations

• Sanitation procedures for receiving, handling, transporting, and storage activities
• Quality control protocols to ensure food suitability and safety
• Allergen control and cross-contact prevention measures
• Procedures for handling contaminated or adulterated products
• Defined sanitation oversight responsibilities and accountability
• Testing protocols, including:
- ◦ Chemical testing
- ◦ Microbiological analysis
- ◦ Extraneous material evaluation

B. Raw Material & Ingredient Control

• Incoming inspection and segregation procedures for raw materials
• Allergen identification, labeling, and rework management
• Washing and sanitizing procedures, including water quality controls
• Storage practices addressing temperature, humidity, and bulk handling
• Contaminant control measures (e.g., aflatoxins, pests, natural toxins)
• Thawing, reconditioning, and handling procedures
• Alignment with FDA defect action levels and regulatory limits

Deliverables

• SOP for General Manufacturing, Processing, and Sanitation Operations
• SOP for Quality Control Oversight and personnel responsibilities
• SOP for Raw Material Receiving, Inspection, and Segregation
• SOP for Rework and Allergen Ingredient Management
• SOP for Washing, Thawing, and Holding Procedures
• SOP for Non-Conformance Handling and product disposition
• Recordkeeping logs, including:
- ◦ Ingredient inspection records
- ◦ Rework tracking logs
- ◦ Testing and verification records
• Training materials, including onboarding guides and competency quizzes
• CFR reference summary for internal audits and compliance verification

Optional Program Enhancements

• Additional SOPs for specific processing equipment and operational areas
• Expanded ingredient-specific control procedures (e.g., allergen, frozen, bulk liquid)
• Testing program development for microbiological, chemical, and contaminant analysis
• Staff training modules and virtual training sessions
• Annual SOP review and update support
• Multilingual SOP and training documentation
• Mock audits focused on compliance with §117.80 requirements

Ideal For

• FDA-regulated food manufacturers and processors
• Facilities handling multiple raw materials and ingredient types
• Operations requiring structured CGMP and sanitation controls
• Companies preparing for FDA inspections or third-party audits
• Businesses seeking to standardize operational and raw material control procedures

Program Value

• Ensures compliance with FDA CGMP requirements for processing and controls
• Strengthens control over raw materials and production activities
• Reduces risk of contamination and adulteration
• Improves operational consistency and quality assurance
• Provides audit-ready SOPs and documentation for regulatory inspections

Fees and Subscriptions

Base SOP Package

Includes 1 process flow + 1 ingredient category + 1 area → $595

Add-On Modules (Customizable):

Add-On	Description	Price
🏭 Additional Processing Equipment SOP	Blenders, slicers, kettles, mixers, etc.	$150/equipment
📦 Additional Operational Area SOP	Receiving, QA room, dry/cold/frozen storage, etc.	$125/area
🌾 Additional Ingredient Type SOP	Allergen-specific, frozen, bulk liquid, etc.	$100/type
🧪 Testing Program SOP	Microbial, chemical, aflatoxin, extraneous material	$200
📚 Training Deck & Quiz	Visuals, policies, and validation questions	$200
🧑‍🏫 Virtual Training Session	60 mins with sanitation & QC team	$250

Sample Packages

Package	Inclusions	Price
Starter	Base + 2 equipment + 1 area	$895
Operational Control	Base + 3 ingredients + 2 areas + Training Deck	$1,300
Comprehensive	Base + 5 equipment + 3 ingredients + 3 areas + Virtual Session	$2,150