CGMP Compliance Program Implementation & Oversight
Subpart B CGMP Compliance Implementation & Sanitary Controls Program Comprehensive Setup and Oversight Based on 21 CFR Part 117, Subpart B
To help food facilities implement, document, and maintain full compliance with FDA’s CGMP requirements under Subpart B, ensuring proper hygienic practices, sanitary design, and operations that minimize allergen cross-contact and food adulteration.
Scope of Work
Initial Program Setup (One-Time Fee):
1. Personnel Hygiene & Disease Control Protocols
- • Create SOPs for personnel illness reporting, personal hygiene, and protective attire
- • Develop signage, orientation materials, and supervisor checklists for Subpart B §117.10
2. Facility Sanitation & Plant Design Evaluation
- • Audit plant grounds, drainage, airflow, lighting, and pest control systems
- • Assess sanitary design for §117.20 and §117.35 compliance
- • Recommend corrective actions for sanitary construction and operations
3. Equipment, Utensils & Environmental Control Review
- • Evaluate §117.40 compliance (e.g., cleanable surfaces, corrosion resistance, air/gas treatment)
- • Provide guidance on preventive maintenance and calibration schedules
4. CGMP-Based Process & Control Review
- • Map operations per §117.80, including allergen separation, microbial controls, and sanitation protocols
- • Support development of documentation for raw material, rework, and ingredient handling
5. Warehousing & Distribution Controls
- • Implement allergen and contamination controls for §117.93 and §117.95 requirements
- • Draft procedures for human food by-product handling for animal food
6. Sanitary Facility & Utility Control Program
- • Establish SOPs and layout for plumbing, toilet facilities, hand-washing stations, and waste management (§117.37)
7. Defect Action Level Monitoring SOPs
- • Review quality control activities per §117.110
- • Establish monitoring processes for FDA Defect Levels Handbook compliance
8. CGMP Recordkeeping Framework
- • Provide Subpart F-compliant logs, inspection forms, and verification tools
- • Train responsible personnel on record creation and retention
Deliverables
• CGMP SOPs and facility-specific sanitation protocols
• Facility hygiene and sanitation assessment reports
• Personnel hygiene guidelines and training support
• Equipment and surface sanitation logs
• Corrective and Preventive Action (CAPA) templates
• Warehouse and animal by-product controls documentation
• Monthly CGMP audit summaries
• Certificate of Program Implementation and Compliance Support
Fees and Subscriptions
Ongoing Monthly Maintenance Services:
- ✔ Monthly CGMP walkthroughs (virtual or physical)
- ✔ Review of facility conditions, pest control logs, and sanitation checklists
- ✔ SOP updates for allergen cross-contact, equipment sanitation, and employee hygiene
- ✔ Quarterly staff refresher training on CGMP practices
- ✔ Support for FDA inspections or third-party audit preparation
- ✔ Monitoring of environmental conditions and corrective actions
- ✔ Quarterly CGMP compliance report
- ✔ Priority advisory for operational changes and compliance upgrades
Pricing Structure:
| Service Tier | One-Time Setup Fee | Monthly Maintenance Fee | Coverage |
|---|---|---|---|
| Standard | $2,500 | $950/month | Single production category, up to 25 employees |
| Enhanced | $4,200 | $1,800/month | Two production zones/categories, up to 50 staff |
| Premium | $5,800 | $2,750/month | Multi-category production + warehousing, up to 100 staff |
| Enterprise | Custom Quote | Custom Quote | Multi-site coverage, large operations, or international distribution |
• Additional Add-On: Equipment Sanitation SOP Development – $750/unit type
• Add-On: CGMP Employee Orientation Package (Slides + Videos + Quiz) – $1,200
Ideal For:
- • U.S. and foreign food manufacturers, processors, co-packers, and packers
- • Facilities operating under multiple product types (e.g., bakery, RTE, dairy, supplements)
- • Firms subject to third-party or FDA audits
- • Contract manufacturers needing documented CGMP conformance
- • Startups building new production facilities needing turnkey CGMP setup