Dietary food supplements
Dietary and food supplements exported to or sold within the U.S. must comply with Good Manufacturing Practices (GMPs) as set forth in by U.S. federal regulations 21 CFR part 111 and applicable portions of 21 CFR 117, regardless of where in the world they are made. To support supplements manufacturers and brands demonstrate regulatory compliance, a commitment to best practices and quality, and meet increasingly stringent US retailer requirements, Eurofins Assurance offers a dietary and food supplements GMP process certification programme covering these important regulations and standards in the U.S. market, namely 21 CFR 111/117 and NSF/ANSI 455-2-2024.
Certification requirements of 21 CFR 111/117 and NSF/ANSI 455-2-2024
Working in compliance with ISO 17065 standards for impartial conformity assessment, our dietary and food supplements GMP process certification programme provides a smart solution for industry to stay compliant cost-effectively. Companies can choose between two certification technical scopes to best meet the requirements specified by customers and relevant stakeholders. Both scopes offer a process certification approach based on international standards for conformity assessment. This approach is designed to evaluate whether dietary supplement GMPs are fully implemented across all product types and major manufacturing technologies used onsite. While both options follow the process certification approach, the technical standards evaluated vary depending upon the scope selected:
21 CFR 111/117
The audit scope of 21 CFR 111/117 includes 21 CFR 111, 21 CFR Part 121, 21 CFR Part 117 (Subparts A, B, F), and 21 CFR Part 1.511, and is organised according to regulations on the following:
- Quality system
- Facilities and equipment
- Material and supplier management
- Production system
- Packaging system
- Laboratory system
NSF/ANSI 455-2-2024
The audit scope of NSF/ANSI 455-2-2024 includes 21 CFR part 111, 21 CFR Part 117, 21 CFR part 121, 21 CFR Part 11, 21 CFR Part 1.511, 21 CFR Part 1.906, 21 CFR Part 1, Subpart O and 21 CFR Part 1.908. The standard is organised in a quality systems approach similar to ISO 9001 and includes:
- Context of the organisation
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
- Non-grading requirements
A GMP certificate of conformity and the Eurofins Assurance certification marks are issued after all programme requirements are met. You are then able to market your certification to your customers and distinguish yourself from competitors.
Dietary supplement GMP certification process overview
To initiate the certification process, Eurofins Assurance will collect detailed information about your company manufacturing sites, including some pre-audit documentation to ensure preparedness and proper audit scope and duration is agreed.
The audit duration is based upon the scope and complexity of the operation but is usually 2-3 days for a single location.
Dietary supplements GMP process certification documentation
Manufacturers who meet all certification requirements receive a GMP certificate of conformity issued by Eurofins Healthcare Assurance. Our dietary supplement GMP certificates are accepted by some renowned retailers and brands as conformity document.
Companies are also licensed to use and display the Eurofins dietary supplement GMP certification mark on corporate marketing materials to communicate the achievement and highlight the company commitment to quality and continuous improvement.
Please refer to the Policies and Procedures for Good Manufacturing Practices (GMPs) and Management Systems Certification. The certification is conducted by Eurofins Assurance Audit and Certification Services US, LLC and the Terms & Conditions can be viewed here.
Why choose Eurofins Assurance for your dietary supplement GMP certification?
With experts in the U.S. and around the world, the Eurofins Healthcare Assurance team have decades of experience with dietary and food supplements regulations and manufacturing best practices to support your FDA compliance and meet retailer and brand expectations. Our team are third party conformity assessment experts and leverage the most experienced, well-trained auditors located globally to support customers with geographic proximity.
For dietary supplements GMP certification, Eurofins Assurance also offers:
This programme is accredited to ISO/IEC 17065 by ANAB, demonstrating competence, impartiality, and credibility.
Certification is delivered by Eurofins Assurance Audit and Certification Services US, LLC. You can view relevant scope of accreditation from the ANSI National Accreditation Board (ANAB) here.
Our certification activities are provided by independent Certification Bodies separately from any consulting activities. Impartiality is safeguarded by Eurofins Assurance’s relevant policies to avoid conflicts of interest.