Master cGMP & HARPC Compliance with Ease
For food manufacturers, processors, and co-packers, compliance with the FDA’s current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) isn’t just a regulatory checkbox—it’s a cornerstone of product safety, consumer trust, and operational success.
But building a fully compliant documentation system from scratch can be overwhelming, time-consuming, and prone to error.
That’s why PCQIServices.com offers a structured solution: a complete SOP documentation package tailored specifically to 21 CFR Part 117 requirements for human food. Whether you’re preparing for an inspection, onboarding a new QA team, or setting up a new facility, our editable templates save time and help ensure audit-ready compliance.
What Are cGMP and HARPC?
cGMP (current Good Manufacturing Practices) under 21 CFR Part 117 Subpart B outlines the basic hygienic and operational requirements for food facilities to prevent contamination and ensure product quality.
HARPC (Hazard Analysis and Risk-Based Preventive Controls), outlined in Subparts C and G, is a requirement under the Food Safety Modernization Act (FSMA). It requires companies to:
- • Conduct a hazard analysis
- • Identify and implement preventive controls
- • Monitor and verify effectiveness
- • Maintain records and take corrective actions when needed
What’s Included in the Documentation Package?
At PCQIServices.com, we provide a full set of editable SOP templates covering essential quality and safety processes for human food operations:
- ✅ GMP SOPs – Covering personnel hygiene, sanitation, pest control, equipment maintenance, production environment, and allergen control
- ✅ HARPC SOPs – Addressing hazard identification, process controls, sanitation preventive controls, supply-chain controls, and corrective action protocols
- ✅ Recordkeeping Forms – Daily logs, monitoring forms, verification checklists, and corrective action reports
- ✅ Organizational Customization Guide – Instructions to adapt each template to your facility’s structure, roles, and risk profile
- ✅ Audit Preparation Checklist – Ensures that your documentation package aligns with FDA inspection expectations
Who Is This For?
This documentation package is ideal for:
- • Human food processors launching or scaling operations
- • Co-packers and co-manufacturers managing multiple product lines
- • Private labelers needing turn-key food safety documentation
- • New FSMA registrants preparing for initial FDA inspection
- • Facilities implementing or refreshing their Preventive Controls Qualified Individual (PCQI) plan
Why Use a Pre-Developed SOP System?
Using a structured SOP documentation package from PCQIServices.com allows you to:
- ✔️ Save time developing compliant content from scratch
- ✔️ Ensure consistency across your facility or supplier network
- ✔️ Align with 21 CFR Part 117 without legal guesswork
- ✔️ Prepare for FDA inspections and third-party audits
- ✔️ Support PCQI-led food safety plans with complete documentation
Get Audit-Ready Faster
Food safety documentation shouldn’t be a barrier to growth—it should be a driver of it. With our cGMP & HARPC Compliance SOP Templates, you can implement a system that works, meets regulatory expectations, and reinforces your commitment to quality and compliance.
Ready to Simplify Compliance?
Don’t wait until an inspection to find the gaps in your documentation.
👉 Visit PCQIServices.com to download your SOP template package and take the next step toward operational confidence and regulatory success.