CSQ CERTIFICATION
The CSQ Certification Program and applicable standards were built around ISO/IEC 17067
cGMP Food Processing Audit & Certification Services
Kiwa ASI's cGMP Food Processing Audit is a HACCP-based third-party assessment that verifies your food manufacturing facility meets current Good Manufacturing Practices (cGMP) under 21 CFR Part 117 — protecting your products, your consumers, and your brand.
- HACCP-Based
- 21 CFR 117 Aligned
- Annual Certification
What Is a cGMP Food Processing Audit?
A cGMP food processing audit is a HACCP-based third-party assessment designed to verify that food processing manufacturing facilities meet the basic food safety and food defense requirements of retailers, regulatory agencies, and the general public. Benchmarked against 21 CFR Part 117, it is one of the most comprehensive audit programs available for the food processing industry.
Kiwa ASI's cGMP Food Processing Audit Program (Version 2.0, effective January 2026) provides a comprehensive framework for evaluating the competence of a facility's food safety management system, its documented procedures, and the effectiveness of those procedures in controlling and mitigating food safety and food defense risks. The audit criteria are founded on 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, while integrating globally recognized industry best practices that exceed baseline regulatory requirements.
Though primarily framed around cGMP standards, the audit also incorporates principles from cGDP (Current Good Distribution Practices) and cGSP (Current Good Storage Practices) when assessing broader supply chain and logistical activities, giving you a holistic evaluation of your food processing safety systems.
HACCP-Based Third-Party Assessment
Verifies food manufacturing facilities meet the basic food safety and food defense requirements of retailers, regulatory agencies, and the general public.
21 CFR Part 117 Compliance
Benchmarked against 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.
Food Safety Management System
Evaluates the competence of a facility's documented procedures and their effectiveness in controlling and mitigating food safety and food defense risks.
Supply Chain & Storage Coverage
Incorporates cGDP (Current Good Distribution Practices) and cGSP (Current Good Storage Practices) for a holistic evaluation of broader logistical activities.
WHO IT'S FOR
Who Needs a cGMP Food Processing Audit?
The cGMP Food Processing Audit applies to any facility that handles, manages, manufactures, stores, or distributes food or food contact products. If your operation produces, processes, or packages food intended for human consumption, this audit is designed for you.
Food manufacturers
Food processors
Co-packers and contract manufacturers
Ingredient suppliers
Food warehouses and distribution centers
Many major food retailers and brand owners now require their suppliers to hold a recognized third-party food safety audit. A cGMP certification from Kiwa ASI demonstrates that your facility operates under verified food safety controls, helping you meet customer requirements, protect consumers, and maintain market access.
All facilities located inside the United States, or facilities outside the United States that export to the U.S., must also meet all applicable FDA and USDA regulatory requirements. International facilities must meet regulatory requirements for where the product is manufactured and/or sold. The Kiwa ASI cGMP Audit Criteria shall not be adopted in lieu of regulatory requirements.
YOU'VE DONE THE PREP WORK
Ready to Schedule Your cGMP Food Processing Audit?
You know the requirements — now let Kiwa ASI handle the rest. Request a quote or talk to our team about scheduling your audit around your production cycle.
ADVANTAGES
What Are the Advantages of cGMP Food Processing Certification?
Achieving cGMP certification through Kiwa ASI provides food manufacturers with a verified standard of food safety excellence that meets retail buyer expectations and regulatory alignment. Here are the key benefits:
Retail & Buyer Access
Major food brands and retailers increasingly require their suppliers to hold a third-party food safety audit. A cGMP certification opens doors to new business and protects existing customer relationships.
Regulatory Alignment
The audit criteria are built on 21 CFR Part 117, ensuring your facility's practices align with FDA requirements for current Good Manufacturing Practices, hazard analysis, and risk-based preventive controls.
Reduced Food Safety Risk
The HACCP-based approach systematically identifies and controls biological, chemical, and physical hazards — from allergen cross-contamination prevention to environmental monitoring and temperature-controlled storage.
Supply Chain Confidence
Certification provides documented assurance to your customers that food products are manufactured, stored, and distributed under controlled conditions that protect product safety and integrity.
Continuous Improvement
Annual audit cycles drive ongoing improvement to your food safety management system. Each audit identifies strengths and areas for enhancement, building a culture of food safety excellence over time.
Comprehensive Coverage
The audit evaluates your entire operation across three modules, Food Safety Management System, cGMP practices, and HACCP, plus allergen management, food defense, traceability, and recall readiness in a single assessment.
What Does an Audit Cover?
The Kiwa ASI cGMP Food Processing Audit is structured around three core modules that evaluate every critical aspect of your food safety management system. The audit also includes a live mock recall exercise that must be completed in under two hours during the auditor's visit.
MODULE 1
Food Safety Management System
Management commitment to food safety, complaint management, document control, training programs, licensing, and certification integrity. This module evaluates the foundational elements of your facility's food safety infrastructure.
MODULE 2
Current Good Manufacturing Practices (cGMP)
The largest module of the audit, covering 15 critical operational areas including processing controls, foreign matter prevention, sanitation, pest control, chemical management, and facility design.
MODULE 3
HACCP Plan
Assessment of your Hazard Analysis and Critical Control Points system — including a multidisciplinary HACCP team, product descriptions, process flow diagrams, hazard analysis, CCPs, monitoring, corrective actions, and FSMA Food Safety Plan requirements where applicable.
FOOD DEFENSE
Food Defense & Threat Assessment
Food defense plan documentation, threat assessments, a designated Food Defense Qualified Individual (FDQI), visitor management, personnel screening, secure receipt and transportation protocols, and intentional adulteration prevention.
TRACEABILITY
Traceability & Recall Readiness
Lot identification, hold and release procedures, rework and repacking protocols, documented recall programs, and a live mock recall exercise that must be completed in under two hours during the auditor's visit.
COMPLIANCE
FSMA & Regulatory Integration
Facilities subject to FSMA must maintain a documented Food Safety Plan overseen by a designated Preventive Controls Qualified Individual (PCQI) who holds valid PCQI training certification.
How Should You Prepare for a cGMP Food Processing Audit?
Proper preparation is the foundation of a successful cGMP food processing audit. Here is a step-by-step roadmap to help your facility get ready, whether this is your first audit or an annual recertification.
01
Review the cGMP Audit Criteria
Thoroughly review all three modules of Kiwa ASI's cGMP Audit Criteria — Food Safety Management System, cGMP practices, and HACCP — and incorporate the requirements into your food safety management program. Contact Kiwa ASI to request the current audit standard document.
02
Conduct an Internal Audit
Perform an internal self-assessment using the cGMP Audit Criteria as your checklist. Identify gaps in your documentation, facility conditions, or operational practices. Alternatively, order a Mock Audit from Kiwa ASI for an unscored, expert-led pre-assessment.
03
Build and Update Your Documentation
Ensure all required documented procedures are current, approved, and accessible — including your HACCP plan, food defense plan, allergen management program, cleaning and sanitation program, environmental monitoring program, supplier approval records, training matrices, and recall procedures.
04
Train Your Team
Verify that all personnel — including temporary employees and contractors — have received appropriate training on cGMPs, HACCP, food defense, allergen management, and their role-specific responsibilities. Ensure training records are up to date and include competency verification via signature, quiz, or exam.
05
Test Your Traceability and Recall System
Run a mock recall exercise internally — tracing one step back to suppliers and one step forward to customers — and complete it within two hours. During the audit, the auditor will require your facility to complete a live mock recall exercise in under two hours.
06
Ensure 60 Days of Production Records
Your facility must have a minimum of 60 days of production records before the certification audit. If your site cannot provide 60 days of records, Kiwa ASI holds sole discretion to continue or abort the audit.
07
Apply and Schedule Your Kiwa ASI Audit
Submit your application to Kiwa ASI, finalize facility details, personnel, and scope information, and coordinate scheduling with the Kiwa ASI Planning team. Your facility must be in active production on the day of the audit.
Why Choose Kiwa ASI for Your cGMP Food Processing Audit?
Kiwa ASI brings nearly a century of food safety auditing experience to the food manufacturing industry. Here's what sets us apart:
Experience
Food Processing Industry Expertise
Our auditors understand the unique challenges of food manufacturing — from allergen management and environmental monitoring to temperature-controlled storage and process validation. You'll work with auditors who speak your industry's language.
Scheduling
Comprehensive, Standards-Driven Program
The cGMP Food Processing Audit Program (Version 2.0) was built on 21 CFR Part 117 and integrates globally recognized best practices. It covers your food safety management system, cGMP operations, and HACCP plan in a single, rigorous assessment — ensuring you meet both regulatory expectations and the demands of today's retail buyers.
Preparation
Mock Audits and Pre-Assessments
First-time applicants or facilities looking to strengthen their food safety systems can request an optional Mock Audit — an unscored, feedback-driven assessment that highlights compliance gaps before the official certification audit. Mock audits cannot be converted into scored audits.
Support
Clear Communication and Support
From application through certification, Kiwa ASI's planning team coordinates every step — aligning audit scheduling with your production cycle, assigning qualified auditors to your scope, and providing clear, actionable findings with defined corrective action timelines.
Partnership
Global Kiwa Network
As part of the global Kiwa group, Kiwa ASI offers the scale and resources of an international certification body with the personalized service and accessibility of a domestic partner. Whether your facility is in the U.S. or exporting internationally, we ensure consistent audit quality.
Frequently Asked Questions
What is a cGMP food processing audit?
A cGMP food processing audit is a HACCP-based, third-party assessment that evaluates whether a food manufacturing facility meets current Good Manufacturing Practices (cGMP) as defined by 21 CFR Part 117. The audit covers three modules — Food Safety Management System, cGMP operational practices, and HACCP — and results in a scored certification valid for one year.
Who needs a cGMP food processing certification?
Any facility that manufactures, processes, stores, or distributes food products can benefit from cGMP certification. Many major food brands and retailers require their suppliers to hold a recognized third-party food safety audit. The certification applies to food manufacturers, processors, co-packers, ingredient suppliers, and warehouses handling food products.
How does the cGMP food processing audit address allergen management?
Allergen management is a core component of the audit under Processing Controls (Module 2). The audit evaluates your procedures for preventing unintended allergen cross-contamination, allergen identification and handling, changeover and sanitation procedures, environmental swabbing and product testing verification, allergen storage segregation, and allergen labeling accuracy and regulatory compliance.
How long does a cGMP food processing audit take?
The minimum duration for a certification audit is one full day (approximately 8 hours). Actual audit duration varies based on facility size, number of employees, product types, number of HACCP plans, and the overall scope of the audit. Kiwa ASI will provide a duration estimate during the application process, and audits are coordinated in half-day increments.
How often do I need to be audited?
cGMP audits are conducted annually to maintain certification. Your certificate expires 30 days after the one-year anniversary of your last certification audit. It's important to schedule audits with sufficient lead time to avoid a certificate lapse, as the technical review and approval process may extend beyond the expiration date.
Can I get a mock audit before my official certification audit?
Yes. Kiwa ASI offers optional Mock Audits — unscored pre-assessments that provide valuable feedback on compliance gaps. Mock audits help first-time applicants and existing certified sites identify areas for improvement before the scored certification audit. A Mock Audit cannot be converted into a scored Certification Audit once it has begun.
What score do I need to pass the cGMP audit?
Your facility needs a score of 70% or higher to receive a certificate. Scores of 90–100% earn an Excellent rating, 80–89% earn a Good rating, and 70–79% earn a Complies rating. A critical non-conformity (such as active contamination or falsification of records) results in an automatic score of 0% and no certificate is issued.
What is the difference between the cGMP food processing and food packaging audits?
Both audits follow the same three-module structure (Food Safety Management System, cGMP, and HACCP) and the same scoring methodology. The key difference is the scope: the food processing audit is designed for facilities that manufacture, handle, and process food products intended for human consumption, with expanded criteria for allergen management, environmental monitoring, temperature-controlled storage, and product-specific hazard analysis. The food packaging audit is tailored for facilities producing food contact packaging materials.
All consulting services are offered through ASI Training and Consulting, LLC. All activity is conducted separately from our accredited certification body, ASI Food Safety, LLC, in order to safeguard against any conflicts of interest.