Preventive Controls Program Development
Compliant with 21 CFR §117.135 — Hazard-Based Preventive Controls
A compliant Preventive Controls Program is a core requirement of a Food Safety Plan under 21 CFR §117.135, ensuring that identified hazards are effectively controlled through risk-based, scientifically supported measures, and this service provides a structured, PCQI-led approach to developing and implementing preventive controls aligned with the Food Safety Modernization Act (FSMA), fully integrated into your overall Food Safety Plan.
Program Objective
To develop and implement a comprehensive Preventive Controls Program that: Preventive Controls Program that:
- • Ensures effectiveness of preventive controls across all operations
- • Establishes structured monitoring and documentation practices
- • Defines corrective action and correction procedures
- • Implements verification and validation systems
- • Maintains audit-ready records for FDA inspections and third-party audits
- • Identifies hazards requiring control based on hazard analysis
- • Establishes risk-based preventive controls tailored to products and processes
- • Defines monitoring, corrective action, and verification requirements
- • Ensures compliance with FSMA Preventive Controls regulations
- • Maintains audit-ready documentation for FDA inspections
Deliverables
1. Preventive Controls Identification & Implementation Plan
- • Evaluation of process flow to identify hazards requiring preventive controls
- • Determination of Critical Control Points (CCPs) where applicable
- • Development of allergen, sanitation, and supply-chain controls
- • Alignment with facility operations and specific product risks
2. Written Preventive Controls Program
- • Development of required written procedures for each control type
- • Integration with the Food Safety Plan under 21 CFR §117.126
- • Customization based on facility processes and product categories
3. Process Controls
- • Procedures to manage critical parameters (time, temperature, pH, water activity)
- • Establishment of minimum and maximum critical limits
- • Monitoring forms and routine documentation templates
4. Food Allergen Controls
- • Assessment of allergen cross-contact risks across all operations
- • Label control procedures to prevent misbranding under FD&C Act Section 403(w)
- • Implementation of visual controls, physical segregation, and staff procedures
5. Sanitation Controls
- • Procedures for cleaning and sanitizing food-contact surfaces and equipment
- • Employee hygiene and contamination prevention protocols
- • Environmental monitoring and cross-contamination mitigation controls
6. Supply-Chain Controls
- • Integration of supply-chain program requirements under 21 CFR Part 117, Subpart G
- • Identification and oversight of supply-chain-applied controls
- • Development of supplier approval, verification, and audit procedures
7. Recall Plan Integration
- • Development and review of recall procedures in accordance with 21 CFR §117.139
- • Definition of recall triggers, designated roles, and external communication protocols
- • Integration with internal lot traceability and product disposition systems
8. Additional Preventive Controls & GMP Integration
- • Development and refinement of GMP-based prerequisite operational controls
- • Personnel hygiene standard operating procedures and training modules
- • Internal verification processes to ensure consistent cross-facility implementation
Fees and Subscriptions
Service Fee Structure
| Plan | Description | One-Time Fee | Included Support |
|---|---|---|---|
| Foundational Plan | Preventive Controls for 1 Product Line | $1,750 | Includes process, allergen, and sanitation controls |
| Standard Facility Package | Controls for Multi-Line Facility (Up to 5 SKUs) | $3,200 | Includes supplier controls, monitoring templates, and CCP documentation |
| Enterprise Compliance Suite | Facility-wide control systems + audit simulation | Custom Quote | Includes validation aid, training module, and recall plan development |
Ideal For
- • FDA-regulated food facilities establishing Preventive Controls systems
- • Contract manufacturers, co-packers, and private labelers
- • Facilities transitioning from HACCP to HARPC compliance
- • U.S. importers supporting preventive control requirements under FSVP
- • Companies preparing for FDA inspections or third-party audits
Program Value
- • Establishes a complete hazard-based preventive control system
- • Ensures alignment with FSMA regulatory requirements
- • Reduces food safety risks through structured control implementation
- • Strengthens audit readiness and regulatory defensibility
- • Supports scalable compliance across products and operations
Need Expert PCQI Support?
Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.
