CSQ CERTIFICATION
The CSQ Certification Program and applicable standards were built around ISO/IEC 17067
cGMP Certification & Audit Services
Kiwa ASI helps manufacturers, Packers, and Distributors achieve cGMP certification through comprehensive audits aligned with current Good Manufacturing Practice regulations. Our updated cGMP Audit Program 2.0 reflects the latest requirements and expectations for modern food processing, food packaging, and distribution operations, keeping your facility ahead of regulatory expectations.
- Retail & Buyer Confidence
- Operational Efficiency
- Reduced Risk
cGMP Certification
ASI can assist with cGMP audits and certification by offering comprehensive evaluation and compliance services to ensure that manufacturing practices meet regulatory requirements and industry standards, resulting in cGMP certification.
Lets Talk cGMP
At ASI, we use the term cGMP (Current Good Manufacturing Practices) as opposed to the outdated term GMP (Good Manufacturing Practices), because we recognize that safety and quality best practices are constantly changing, and it's our job to constantly be up-to-date on requirements.
cGMP is the first line of defense in keeping your product safe. Regardless of the product type, ALL food manufacturers and service professionals are required to follow cGMP according to the Code of Food Regulations (CFR).
FDA and USDA Auditors will be looking for implementation of these practices. Failure to follow these practices puts your product and business at risk.
cGMP Audit Overview:
A cGMP audit is an assessment of a facility's compliance with current Good Manufacturing Practice (cGMP) regulations.
During a cGMP audit, a qualified auditor will review the facility's operations, processes, and documentation to ensure that they meet cGMP requirements. The auditor will evaluate various aspects of the facility, including:
- Equipment and facility maintenance: The auditor will evaluate the facility's equipment and infrastructure to ensure that they are properly maintained and cleaned.
- Documentation: The auditor will review documentation related to production, quality control, and testing to ensure that it is complete, accurate, and properly maintained.
- Standard operating procedures: The auditor will review the facility's standard operating procedures (SOPs) to ensure that they are up-to-date and accurately reflect the facility's processes.
- Personnel: The auditor will review the facility's personnel training records and qualifications to ensure that they are adequate for the tasks being performed.
- Quality control: The auditor will review the facility's quality control procedures to ensure that they are adequate for maintaining product quality and safety.
What Is cGMP Certification?
cGMP certification is formal recognition that a manufacturer consistently produces products in compliance with the current Good Manufacturing Practice (cGMP) regulations outlined in 21 CFR 110, 21 CFR 111, and 21 CFR 117. It demonstrates that your facility's processes, personnel, equipment, and documentation meet the quality and safety standards required to protect consumers and satisfy retail and regulatory scrutiny.
At Kiwa ASI, we use the term current GMP intentionally, because safety and quality best practices are constantly evolving, and our audit program evolves with them.
NEW
What's New | cGMP Audit Program 2.0
The cGDP Storage & Distribution 2.0 standard is built for warehouse and distribution operations that store and ship fully packaged food products.
Kiwa ASI has launched cGMP Audit Program 2.0, a comprehensive update to our audit standards designed to meet the evolving needs of global food manufacturing, packaging, and distribution operations.
Why Version 2.0 Matters
🔍
Crystal Clear Standards
Refined language and criteria that reduce ambiguity for auditors and facilities alike.
🌍
Global Best Practices
Updated requirements aligned with international food safety, going above that of any one national regulatory body.
📋
Streamlined Structure
A reorganized module framework that makes preparation and reporting more intuitive.
📘
Enhanced Guidance
More actionable direction for facilities working toward first-time certification or recertification.
New Requirements in Version 2.0
Management Commitment to Food Safety
Version 2.0 now requires documented leadership involvement and a formal food safety culture assessment. Senior management must demonstrate active ownership of the facility's food safety program, not just policy sign-off.
Licensing Verification
Facilities must demonstrate compliance with all applicable local, state, and federal business licenses as part of the audit scope.
Certification Integrity
Version 2.0 goes well beyond logo usage. Certified sites must maintain the integrity and credibility of their certification across three key areas:
1. Proper use of certification marks and accurate records: Any certification marks, logos, and certificates must be used in accordance with ASI guidelines, and all records and audit-related information must be accurate and free from falsification or misrepresentation.
2. Transparent scope exclusions: All product, process, or area exclusions must be previously reported to Kiwa ASI, approved, and verified as accurate at the time of the audit.
3. Unrestricted auditor access: The site shall provide auditors unrestricted access to all relevant areas, records, personnel, and processes without obstruction.
Proper use of certification marks and accurate records
The program is now aligned with current Preventive Controls for Human Food requirements, with PCQI oversight automatically required and all program elements mandatory to ensure audits reflect current regulatory expectations.
Enhanced Coverage Areas
- Risk-based hygienic zoning and environmental monitoring programs
- Allergen management protocols for packaging and distribution operations
- Electronic records and document control systems
- Complaint handling procedures and traceability exercises (one step forward / one step back)
- Scope reporting and processes for certification expansion
Improved Audit Reporting
All Version 2.0 audit reports now include section summaries that give facilities a comprehensive program overview. These summaries are informational, not scored separately, but provide a clearer picture of standing across every module.
Ready to Get Started?
Whether you're pursuing cGMP certification for the first time or upgrading to our Program 2.0 standards, Kiwa ASI is here to help.
Which Kiwa ASI cGMP Audit Standard Is Right for You?
Kiwa ASI offers three Version 2.0 audit standards covering food processing, packaging, and storage & distribution operations.
| Standard | Who It Covers |
|---|---|
| cGMP Food Processing 2.0 | Food & beverage product manufacturers covering full processing operations |
| cGMP Food Packaging 2.0 | Manufacturers of food product packaging (direct-contact and non-contact) |
| cGDP Storage & Distribution 2.0 | Warehouse and distribution operations that store and ship fully packaged products |
Download the standards and audit checklists from our cGMP Audit Program 2.0 page. The updated checklists provide a transparent view of all requirements — ideal for gap assessments and pre-audit prep.
Kiwa ASI cGMP V2.0 Training: 8-Hour Comprehensive Course
Stay ahead of evolving compliance standards. This live, instructor-led course provides a practical understanding of Current Good Manufacturing Practices aligned with the new cGMP V2.0 requirements.
8 Hours
Intensive Live Training
A full-day, deep-dive session focusing on building a strong foundation in cGMP principles with an emphasis on practical application and quality excellence.
v2.0
Comprehensive Curriculum
Covers key areas including QMS, documentation control, personnel responsibilities, facility requirements, and the latest data integrity standards.
100%
Audit & Inspection Ready
Learn to manage deviations and CAPA effectively through real-world scenarios, ensuring your facility maintains continuous compliance and audit readiness.
Upcoming cGMP V2.0 Training Dates
All sessions are live virtual, 8:30 AM – 4:30 PM CT. Monday through Friday.
May 6, 2026
8:30 AM - 4:30 PM CT · 8 contact hours
$299
Enroll Now
July 8, 2026
8:30 AM - 4:30 PM CT · 8 contact hours
$299
Enroll Now
September 9, 2026
8:30 AM - 4:30 PM CT · 8 contact hours
$299
Enroll Now
November 4, 2026
8:30 AM - 4:30 PM CT · 8 contact hours
$299
Enroll Now
Need to train 6+ people? Ask about on-site private training — we'll come to you.
What Are the Advantages of cGMP Certification?
cGMP certification provides a competitive edge by demonstrating your commitment to product quality, consumer safety, and regulatory compliance.
Retailer & buyer confidence: Many retailers require cGMP certification as a condition for supplier approval.
Reduced risk: Proactive identification of food safety hazards minimizes the risk of recalls, contamination events, and regulatory action.
Operational efficiency: Structured audits identify process improvements that reduce waste and improve consistency.
Consumer trust: Certification signals your commitment to safety and quality, strengthening your brand.
Continuous improvement: Annual surveillance audits keep your facility on a cycle of regular evaluation and improvement.
Regulatory readiness: Facilities aligned with Program 2.0 are better positioned for FDA inspections, thanks to the integration of Preventive Controls documentation and food safety culture requirements.
NEW IN 2.0
How Should You Prepare for a cGMP Audit?
Preparation is the difference between a smooth audit and a stressful one. Follow these steps to ensure your facility is ready for a cGMP audit under Program 2.0.
1
Appoint a food safety team
Assign a qualified coordinator and cross-functional team members to lead your audit preparation effort.
2
Review applicable FDA regulations
Review Applicable Regulations and Kiwa ASI, LLC’s cGMP Audit Program Requirements relevant to your operations.
3
Organize your documentation
Ensure all SOPs, training records, maintenance logs, and corrective action records are current and accessible. Use the appropriate cGMP Audit Checklist for your facility type to benchmark against the new standards.
4
Conduct a gap analysis
Compare your current systems against the Version 2.0 module framework to identify areas that need improvement.
5
Implement corrective actions
Address any gaps found during your initial gap analysis before the audit date.
6
Train your employees
Ensure all personnel understand cGMP requirements and their role in food safety. If your team needs a refresher, Kiwa ASI offers online and in-person training options.
7
Run an internal audit
Conduct a full mock audit against the three-module structure to test your readiness. If your team is short on time, you can contact Kiwa ASI to perform this internal audit on your behalf and provide a comprehensive final report.
8
Confirm leadership documentation
Ensure Food Safety Management Resources are in place and the site has at least 30-60 days of production records under the cGMP Food Safety Management System.
9
Schedule your Kiwa ASI cGMP Audit
Contact us to set your audit date and confirm the scope of your assessment.
HOW TO PREPARE FOR cGMP AUDIT:
- Understand relevant cGMP regulations for your industry.
- Appoint a dedicated audit preparation team.
- Conduct internal audits to identify non-compliance issues.
- Maintain organized and accurate documentation.
- Ensure employees are well-trained in cGMP requirements.
- Regularly maintain facilities and equipment.
- Evaluate supplier cGMP compliance.
- Update and review quality control and testing protocols.
- Conduct mock audits to identify and address issues.
- Implement corrective and preventive actions (CAPA) for deficiencies.
- Prepare necessary audit documents and policies.
- Schedule the audit and understand its scope.
- Be transparent and cooperative on the audit day.
- Address audit findings promptly with a corrective action plan.
The following are the cGMP audit services ASI provides:
cGMP Food Safety Mock Audit – The auditor will walk through the cGMP food safety audit process, go over every question on the audit form and help you prepare for a scored audit. This is for clients that have not had audits before, are new to the industry or have not had an audit in a while.
cGMP Food Safety Scored Audits – ASI can perform the scored audit to satisfy your customer’s requirements. We offer different types of cGMP food safety audits specific to the facility being audited. Most companies require audits annually.
Customized Food Safety Audit Forms – Our experts can customize audit forms and audit programs for your different facilities and supply chains. The criteria can include your company policies and procedures so all locations comply with the cGMPs and management guidelines. Companies perform these audits annually, semi-annually and quarterly.
Supplier Programs – we can ensure that your products are being safely handled and protected following the cGMPs throughout your supply chain. Companies perform these food safety audits annually, semi-annually and quarterly.
What are the ADVANTAGES of cGMP Certification?
Besides meeting regulatory and customer requirements, there are numerous other benefits to receiving a cGMP audit. Some of these benefits include the following:
- Improved quality control: cGMP certification requires strict adherence to quality control processes, which can help improve product quality and reduce the risk of defects and product recalls.
- Increased customer trust: cGMP certification is recognized globally and can help build customer trust by demonstrating that a company is committed to producing high-quality products that meet regulatory requirements.
- Better product consistency: cGMP certification requires standardized processes for product manufacturing and testing, which can help ensure consistent product quality and reduce variability in product performance.
- Competitive advantage: cGMP certification can help companies stand out from competitors and win contracts with customers who require or prefer cGMP-certified suppliers.
Frequently Asked Questions
What is cGMP certification?
cGMP certification is formal recognition from a third-party auditor that your facility consistently operates in compliance with FDA current Good Manufacturing Practice regulations. It demonstrates that your processes, personnel, documentation, and quality controls meet the standards required to produce safe, high-quality products.
What is cGMP Audit Program 2.0?
Kiwa ASI's cGMP Audit Program 2.0 is an updated audit standard aligned with FDA Preventive Controls for Human Food rules and current food safety best practices. Version 2.0 adds new requirements around management commitment to food safety culture, licensing verification, certification integrity, allergen management, electronic recordkeeping, and traceability exercises.
Who is required to follow cGMP regulations?
All food manufacturers and service professionals handling food or food-contact materials must follow cGMP under the Code of Federal Regulations. This includes food processors, packagers, distributors, dietary supplement manufacturers, cannabis operators, pet food producers, and cosmetics manufacturers.
How long does a cGMP audit take?
1-5 days depending on facility size, scope, complexity, and applicable audit standard.
How much does a cGMP audit cost?
Costs vary based on facility size, complexity, scope, and location. Contact Kiwa ASI at 1 (800) 477-0778 or info@asifood.com for a customized quote.
How do I prepare for a cGMP audit under Program 2.0?
We will begin in this chapter by dealing with some general quantum mechanical ideas. Some of the statements will be quite precise, others only partially precise. It will be hard to tell you as we go along which is which, but by the time you have finished the rest of the book, you will understand in looking back which parts hold up and which parts were only explained roughly.
Ready to Get Started?
Whether you're pursuing cGMP certification for the first time or upgrading to our Program 2.0 standards, Kiwa ASI is here to help.