CGMP Compliance Documentation & Training Bundle
Subpart B – 21 CFR 117 CGMP Requirements for Human Food
Scope of Work
Bundle Includes:
1. Programs & Policies
- • CGMP Compliance Policy
- • Personnel Hygiene and Health Program
- • Facility Sanitation Policy
- • Equipment & Utensil Control Program
- • Pest Control Policy
- • Plant Design and Maintenance Policy
- • Product Holding, Storage, and Distribution Policy
- • Defect Action Level Management Policy
2. Procedures (SOPs)
- • Hand Washing SOP
- • Sanitary Facility Maintenance SOP
- • Pest Prevention & Control SOP
- • Sanitation SOP for Food Contact Surfaces
- • Waste and Offal Disposal SOP
- • Equipment Cleaning & Maintenance SOP
- • Ice Use & Water Source Control SOP
- • Environmental Monitoring SOP
- • Non-food Contact Cleaning SOP
- • Allergen Cross-Contact Prevention SOP
3. Forms & Records
- • Daily Personnel Hygiene Checklist
- • Sanitation Log (Food & Non-Food Contact)
- • Pest Control Log
- • Equipment Cleaning & Maintenance Log
- • Storage Temperature Monitoring Log
- • Employee Illness Reporting Form
- • Water Quality Monitoring Form
- • Facility Inspection Checklist
- • Corrective Action & Deviation Report
- • Waste Disposal Tracking Log
4. Training Materials
- • Slide Deck: Introduction to 21 CFR 117 Subpart B
- • Job-Aid: CGMP Do’s and Don’ts
- • Employee Cleanliness & Sanitation Quiz
- • Food Contact Surface Cleaning Quick Guide
- • Trainer’s Guide for Supervisors
- • Certificate of Completion Template
- • Refresher Module Access (Annual)
Fees and Subscriptions
Pricing Options
| Plan | Inclusions | Fee |
|---|---|---|
| Standard One-Time Setup | All documentation templates (editable in Word/Excel), training slides, and forms. | $1,500 |
| Enhanced + Virtual Support | Includes 1-hour onboarding call, customization of 3 SOPs, and email support for 30 days. | $2,200 |
| Monthly Maintenance Plan | Includes ongoing updates (based on regulatory changes), document review, and quarterly refresher training module updates. | $450/month |
Optional Add-On Services
• Remote/Virtual CGMP Gap Audit – $1,200 per day
- - Conducted virtually to assess facility practices against 21 CFR Subpart B requirements.
- - Comprehensive in-person evaluation of CGMP compliance; travel costs billed separately.
- - Includes translation of documentation into Spanish, French, or other requested languages.
- - Crosswalk and enhancement of CGMP documentation to meet Global Food Safety Initiative (GFSI) scheme requirements.