cGMP & HARPC Compliance SOP Templates for Human Food

Compliance Documentation Based on 21 CFR Part 117 Requirements

To establish foundational compliance with FDA’s current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human food, this documentation package provides fully editable SOP templates aligned with 21 CFR Part 117. Designed for human food processors, co-packers, and private labelers, these templates support key quality system functions, preventive control planning, and audit-readiness.

Scope of Work

cGMP & HARPC SOP Template Package

Provide FDA-aligned standard operating procedures (SOPs), policies, and work instructions formatted to 21 CFR Part 117 and delivered as editable Word and PDF files. Templates are suitable for immediate use or customization to internal workflows.

Quality and Safety System SOPs

Develop SOP templates supporting each functional area required under 21 CFR 117:

• Personnel Qualification and Hygiene (Subpart B)
• Facility and Grounds Sanitation (Subpart B)
• Equipment and Utensil Maintenance (Subpart B)
• Process and Production Controls (Subpart B)
• Preventive Controls (Subpart C)
• Supply Chain Controls (Subpart G)
• Allergen Control Procedures
• Recall and Traceability Plans (Subpart C)
• Verification and Validation Procedures (Subpart F)
• Complaint Handling and CAPA Procedures
• Records Management and Retention (Subpart F)

Forms, Checklists, and Support Documents Provide relevant logs, registers, and forms necessary to support implementation of the SOPs, including:

• Cleaning and Sanitation Logs
• Preventive Controls Monitoring Logs
• Process Deviation and Corrective Action Forms
• Supplier Verification Checklists
• Product Release Records
• Document Control Registers

Training Package by TrainingAce.pro

Delivered through TrainingAce.pro, this package includes comprehensive training materials such as Presentation Decks, Quizzes, Evaluations, Attendance Logs, and Certificates. Designed to support internal training requirements and enhance staff awareness, these resources ensure consistent knowledge transfer and regulatory preparedness across teams.

Customization Support (Optional)

Client branding, staff role mapping, and workflow terminology can be integrated into the SOPs for an additional one-time customization fee.

Deliverables

SOP Documentation Package

Fully formatted SOPs tailored to 21 CFR Part 117 requirements:

• Provided in both Word and PDF formats
• Each SOP includes document headers, version controls, and cross-reference sections
• Includes a Master SOP Index and Implementation Guide

Forms & Registers

A set of at least 20 support documents including:

• HARPC Plan
• Templates
• Preventive Control Logs
• Sanitation Checklists
• Corrective Action Forms
• Training Records
• Master Document Index

Customization Guide

Instructional guide for internal teams to adapt SOPs to their specific operations, staffing, and production scale.

Fees and Subscriptions

Standard Documentation Package – $1,750.00 (One-Time Fee)

Includes:

• Complete SOP set covering all major 21 CFR 117 requirements • Forms, logs, and checklists • Implementation guidance and document control tools

Add-Ons:

• SOP Customization Support: +$300 • Training Materials Package: +$275 • Additional Recordkeeping Forms Bundle: +$225 • Audit Readiness Walkthrough (1-hour Zoom): +$150 • Annual SOP Update Package: +$475/year • Master Binder Setup (digital or print-ready): +$200

Ideal For:

• Human food manufacturers, processors, and co-packers needing formal food safety documentation • Facilities preparing for FDA FSMA inspections or third-party certifications (SQF, BRCGS, FSSC 22000) • Startups and scale-ups building foundational cGMP and HARPC programs • Importers and exporters seeking to demonstrate robust food safety programs for FSVP and global trade