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CGMP Compliance Documentation & Training Bundle

FDA CGMP SOP Templates & Training for Food Manufacturing Facilities (21 CFR 117 Subpart B)

The CGMP Compliance Documentation & Training Bundle provides a comprehensive, FDA-aligned system with ready-to-use SOP templates, policies, forms, records, and employee training materials to support compliance with 21 CFR Part 117 Subpart B (CGMPs), enabling food manufacturers, processors, packers, and holding facilities to achieve audit readiness, FDA inspection preparedness, and operational standardization through a complete compliance framework without building documentation from scratch.

What’s Included in the CGMP Compliance Bundle

Programs & Policies

FDA-Compliant CGMP Policies for Food Facility Operations:
  • • 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
Supports:
  • • FDA CGMP program implementation
  • • Facility-wide sanitation and hygiene control
  • • Preventive operational compliance
  • • Audit-ready policy documentation

Procedures (SOPs)

Sanitation, Hygiene, and Operational Control SOP Templates:
  • • 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
Supports:
  • • FDA sanitation and hygiene compliance
  • • Cross-contamination and allergen control
  • • Environmental and operational monitoring
  • • Standardized cleaning and maintenance procedures

Forms & Records

CGMP Logs, Checklists, and Compliance Records Templates:
  • • Daily Personnel Hygiene Checklist
  • • Sanitation Log (Food & Non-Food Contact Surfaces)
  • • 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
Supports:
  • • FDA-required recordkeeping
  • • Real-time monitoring and verification
  • • Inspection and audit documentation
  • • Corrective action tracking and compliance evidence
  • • 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

Training Materials

Employee CGMP Training System for FDA Compliance:
  • • 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
  • • Annual Refresher Training Module
Supports:
  • • Employee CGMP training requirements
  • • Workforce hygiene and sanitation awareness
  • • Supervisor-led training implementation
  • • Ongoing compliance through refresher programs

Who This CGMP Bundle Is For

  • • Food manufacturers, processors, and packing facilities
  • • Warehousing and distribution operations handling food products
  • • Compliance managers and QA professionals
  • • Facilities preparing for FDA inspections or third-party audits
  • • Companies aligning with GFSI schemes (SQF, BRCGS, FSSC 22000)

Why This CGMP Bundle Matters

This bundle delivers a complete CGMP compliance documentation and training system aligned with FDA regulatory expectations and real-world operational needs.
  • • Built specifically for 21 CFR 117 Subpart B compliance
  • • Covers policies, SOPs, records, and training in one system
  • • Supports FDA inspections, internal audits, and certification readiness
  • • Eliminates the need to develop documentation internally
  • • Scalable for facility size, product type, and operational complexity

Access & Implementation

A complete CGMP compliance system—structured, audit-ready, and built for real-world implementation.
  • • Access is tailored based on: Facility type and operational scope
  • • Product category and risk level
  • • Level of support required (self-implementation or advisory support)

Optional Add-On Services

• Remote / Virtual CGMP Gap Audit
  • - Conducted remotely to assess facility compliance against 21 CFR 117 Subpart B requirements.
• Onsite CGMP Gap Audit (plus travel expenses)
  • - Comprehensive in-person evaluation of CGMP compliance and facility conditions.
• Regulatory Translation Support
  • - Translation of SOPs and training materials into Spanish, French, or other required languages.
• GFSI Alignment Package (SQF, BRCGS, FSSC 22000)
  • - Enhancement and crosswalk of CGMP documentation to meet GFSI certification requirements.

Get Started with CGMP Compliance Documentation

Looking to implement a CGMP-compliant food safety system without building documentation from scratch?
This bundle provides a ready-to-use, FDA-aligned compliance framework covering:
  • • Sanitation and hygiene programs
  • • Operational control procedures
  • • Monitoring logs and compliance records
  • • Employee training and competency programs
Request access to the CGMP Compliance Documentation & Training Bundle or schedule a consultation to align the system with your facility, products, and operational requirements.

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.