cGMP for Human Food Implementation Set-Up Services
Turnkey FDA Compliance Setup Project for Food Facilities
Our project-based cGMP Implementation Package delivers a complete, customized documentation and rollout system aligned with FDA’s Current Good Manufacturing Practices (cGMP) under 21 CFR 117 Subpart B and other specialized human food GMP standards. Designed for manufacturers who need to set up or overhaul their compliance infrastructure, this service ensures your operations meet FDA expectations—fast, efficiently, and audit-ready.
Ideal For:
- ✓ Food, beverage, and dietary supplement manufacturers (U.S. & international) ✓ Dietary supplement co-manufacturers producing food-type products ✓ Contract manufacturers needing cGMP systems for buyer or FDA expectations ✓ Startups and new facilities requiring turnkey FDA compliance
Scope of Work
A. GMP for Human Food (21 CFR 117 Subpart B) Implementation Set-up Package
Personnel Hygiene and Disease Control Program
- • Develop customized SOP for personal hygiene requirements.
- • Develop customized SOP for illness reporting procedures.
- • Provide supervisor hygiene checklists.
- • Provide staff orientation training materials.
Facility Sanitation and Plant Design Evaluation
- • Assess plant grounds, drainage, pest control, airflow, and lighting systems.
- • Evaluate compliance with sanitary design requirements.
- • Recommend construction and/or operational improvements.
Equipment, Utensils, and Environmental Control Program
- • Review equipment and utensil design for cleanability and corrosion resistance.
- • Establish preventive maintenance SOPs.
- • Develop equipment calibration schedules.
cGMP Process and Operational Controls
- • Map process flows for receiving, storage, processing, packaging, and distribution.
- • Develop SOPs for raw material and rework handling.
- • Establish allergen and microbial control procedures.
Warehousing and Distribution Controls
- • Develop SOPs for storage and handling of finished goods.
- • Develop allergen cross-contact prevention procedures.
- • Provide procedures for by-product handling (e.g., food diverted to animal feed).
Sanitary Facility and Utility Controls
- • Develop SOPs for plumbing systems, water supply, waste management.
- • Develop SOPs for toilets and hand-washing stations.
- • Provide facility layout recommendations to improve sanitation.
Defect Action Level Monitoring Program
- • Review FDA Defect Levels Handbook requirements.
- • Establish SOPs for defect action level monitoring.
- • Provide defect level inspection logs and procedures.
cGMP Recordkeeping and Documentation System
- • Develop Subpart F-compliant forms, checklists, and logs.
- • Provide training materials to staff on document creation, review, and retention practices.
- • Implement Master Document Control system.
B. Ongoing Monthly Maintenance Services (Optional Add-on)
- 1. Regular review and update of allergen, sanitation, and hygiene SOPs.
- 2. Provision of routine cGMP refresher training for personnel.
- 3. FDA inspection readiness support (virtual coaching).
- 4. Environmental monitoring guidance and corrective action recommendations.
- 5. Compliance summary reports scheduled weekly/monthly/bi-monthly/monthly/quarterly.
- 6. Priority advisory services for regulatory or operational changes.
C. GMP and HACCP/HARPC Setup based on specific food categories (Optional Add-Ons)
1. Juice HACCP (21 CFR 120)
- • HACCP Plan development and validation
- • CCP monitoring SOPs and forms development and customization
2. Seafood HACCP (21 CFR 123)
- • HACCP Plan development and validation
- • CCP monitoring SOPs and forms development and customization
3. Low-Acid Canned Foods (21 CFR 113)
- • Scheduled process development assistance
- • Thermal processing and container integrity checks SOP development and customization
- • CCP monitoring SOPs and forms development and customization
- • FDA filing procedures and guidance
4. Bottled Water GMP (21 CFR 129)
- • Source water protection SOP development and customization
- • Sanitation of water systems and containers
- • Bacteriological testing and sampling SOP development and customization
- • Recordkeeping templates for bottled water compliance
5. Infant Formula GMP (21 CFR 106/107)
- • Nutrient control SOP development and customization
- • Quality and safety control procedures and monitoring forms development and customization
- • Shelf-life tracking procedures and monitoring forms development and customization
- • HARPC Plan development and validation
6. Dietary Supplements (21 CFR 111)
- • Customized documentation for quality and process controls, master manufacturing records control and batch processing, label reconciliation, packaging control, and management of component specifications
7. Special Dietary Foods GMP (21 CFR 105)
- • Customized SOPs for specialized dietary food processing
- • Allergen management procedures and monitoring forms development and customization
- • Nutritional labeling compliance SOPs development and customization
8. Human Food Preventive Controls (21 CFR 117 Subparts C & G)
- • Preventive Control Programs SOP development and customization
- • Food Safety Plan development
- • Allergen management procedures and monitoring forms development and customization
- • Product release programs development and customization
- • Recall Plan development and customization
- • Supply-chain programs and forms customization
Deliverables
• Fully customized GMP SOPs for 21 CFR 117 Subpart B (editable Word and PDF formats), including:
- • Facility sanitation and plant design assessment reports
- • Equipment cleaning and maintenance logs
- • Personnel hygiene and training guidelines
- • Warehouse storage and distribution control procedures
- • Pest control and facility monitoring checklists
- • Corrective and Preventive Action (CAPA) procedures and templates
- • Product rework SOPs
- • 21 CFR 117 Subpart F-compliant recordkeeping forms and logs
- • Training materials (lessons for training and comprehension quizzes)
• Records implementation guides
Pricing and Timeline
Base 21 CFR 117 Subpart B cGMP Full Customization Setup
- • Price: $15,000 per facility
- • Timeline: 60 to 75 business days
Add-Ons:
- • Human Food Preventive Controls (21 CFR 117 Subparts C & G) - $7,500 per facility
- • Juice HACCP (21 CFR 120) - $4,500 per product/process
- • Seafood HACCP (21 CFR 123) - $4,500 per product/process
- • Low-Acid Canned Foods (LACF – 21 CFR 113) - $6,000 per product
- • Infant Formula (21 CFR 106/107) - $12,000 per product
- • Bottled Water (21 CFR 129) - $4,500 per facility
- • Dietary Supplements (21 CFR 111) - $4,000 per facility
- • Special Dietary Foods (21 CFR 105) - $3,500 per product
- • Annual SOP Update Package - $1,499 per year
- • Foreign Supplier Verification (FSVP) SOP Toolkit for Importers - $1,550
- • PCQI Monthly End-to-end Compliance Oversight and Management Support - starts at $2,500 per month
Start Your Setup Project Today
This is a done-for-you, one-time setup service designed to launch or bring your facility into FDA compliance — not a subscription, not generic templates, but a fully executed documentation system you can own, manage, and scale.
Let’s build your cGMP system. Contact us for a discovery call or customized quote.