One of the most-asked questions our team has received since the Eurofins Assurance supplement product certification programme launch is – how is product certification different from GMP certification? Follow up questions usually include – why would our brand want to complete an additional product certification, on top of GMP certification? What benefits does product certification bring to my supplement brand?
Whether you represent the brand owner or are a contract manufacturer, we answer these questions in this article, providing objective insights to help you make informed decisions when selecting a certification.
What is GMP certification for the supplement industry?
To make sure everyone begins on even ground, we will start by explaining what GMP (Good Manufacturing Practices) certification really means.
GMP certification evaluates and validates compliance of the manufacturing processes, facilities, equipments, grounds, quality systems, personnel competence, documentation, and change record management of the audited site against GMP requirements set by regulations, public standards, and best practices. Obtaining a GMP certification signifies that a site has a well-controlled and stringent manufacturing process to reduce risk and safeguard product quality.
In the U.S., the dominating regulations for GMP compliance of dietary supplements manufacturing are 21 CFR 111 and 21 CFR 117. As of the time of writing, there are no equivalent regulations in Europe or other major markets such as China and India to the 21 CFR 111 regulation in the US. The principles under 21 CFR 117 related to food safety risk management are more broadly correlated to global standards.
What is supplement product certification?
Product certification for supplements is conducted at the formulation level, providing targeted evaluation of the identity, strength, purity, and quality of finished products manufactured according to a defined product specification. This certification may extend to multiple SKUs where they are based on the same certified formulation and produced under equivalent conditions.
While GMP certification and its evaluation of site quality management systems is a key prerequisite, product certification evaluates a tighter set of criteria specific to a product formulation. In addition to confirming compliance with applicable GMPs, the certification scope includes a detailed review of a product formulation and raw materials inputs against label claims and against standards or protocols for labelling and purity. It incorporates sample collection and independent laboratory testing in accordance with a defined, impartial evaluation plan based on product key attributes and claims. Product label claims are reviewed against test results and supporting documentation prior to an independent certification decision.
To maintain certification, products are subject to ongoing oversight, including annual reassessment and a product manufacturing audit. Certified entities are required to notify the Certification Body of changes to the formulation or claims so that the impact on certification can be assessed and appropriate actions can be taken if further testing is necessary to maintain certification.
In the United States, product certification for dietary supplements is commonly conducted against NSF/ANSI 173 – Dietary Supplements, which emphasizes verification of declared ingredients and the absence of unsafe levels of undeclared contaminants. While similar frameworks may be applied in other regions, formalised standards and requirements can vary globally.
How is product certification different from GMP certification?
While both certifications play important roles, they differ significantly in scope, application and marketing strategy.
GMP certification is an attestation by a qualified third-party that a manufacturing site operates controlled, documented systems designed to consistently produce safe and compliant products. It applies broadly to the manufacturing of product categories and associated manifesting technologies, rather than specific formulations. GMP certification is a small sampling of records from many, and so there is no guarantee any specific product has been reviewed during the process. Certification Marks of Conformity or claims of certification are restricted from being associated with finished products for this reason. When marketing this certification, manufacturers and brands are limited to B2B strategy regarding the process certification, and Marks must be segregated from finished product marketing.
In contrast, since product certification focuses on a defined finished product formulation created through the coordination of the facility’s processes, it verifies not only that the certified product is manufactured in compliance with GMPs, but that this process has been assessed to have produced a product meets specific requirements related to its identity, strength, purity, label claims, and supporting technical documentation. This certification can extend to multiple SKUs where they are based on the same certified formulation. Due to the rigor of this product evaluation, the Certification Mark may be placed on the finished product and claims of Eurofins Assurance certification are authorised.
Viewed together, GMP certification attests to a strong foundational control environment, while product certification attests to validated outcomes for specific formulations to consistently meet defined quality and claim requirements.
Comparison of GMP certification and product certification
| GMP process certification | Product certification | |
| Assessment of Quality Management System (QMS) | Yes, QMS is the backbone of any GMP certification. | Yes, GMP certification is part of the product certification scope. |
| Testing | No. Testing is not required, but test reports or methods could be examined as part of assessing facility GMP compliance. | Yes, testing of finished product or raw materials is required to evaluate the product label claims. |
| Scope | Covers overall manufacturing controls for broad product categories rather than individual products or SKUs. | Applies at the formulation level and may extend to multiple SKUs derived from the same certified base formula. |
| Ongoing surveillance | Yes. GMP certification typically requires an annual audit to maintain certification. | Yes, annual re-testing and re-audit is required. The brand or site owning the product also has an obligation to inform the Certification Body of any change in the product’s specification proactively. |
| Usage of certificate and Certification Mark | Certified sites can display and present the certificates and Certification Marks on company marketing materials regarding the sites’ qualification, process management or other similar aspects. GMP certification marks cannot be used on any product’s packaging and marketing materials. | Certified products are eligible to display the Certification Mark on the product’s packaging and marketing materials. |
Why should supplement brands obtain Eurofins Assurance product certification?
Independent, third- party product certification provides a valuable attestation of product quality that is trusted by retailers, consumers, and brands worldwide. The layers of evaluation required to earn this certification distinguish products from the competition in any market.
GMP certification is widely recognised as a foundational requirement in the supplement industry, demonstrating that products are manufactured under controlled conditions designed to manage risks such as contamination, adulteration, and defects. Whether or not it is mandated in a given market, it provides a clear and credible way for brands to show that their products are produced through well-controlled processes. It can future-proof your compliance in a world of ever more stringent expectations.
In competitive markets, product certification builds on this foundation by providing additional assurance that product claims are independently verified. This can enhance retailer and consumer confidence and support meaningful differentiation. Eurofins Assurance product certification is accepted by some global retailers as meeting their supplier requirements, which can shorten time to shelf, and reduce risk.
For brands looking to strengthen their competitive positioning, product certification provides a clear, independently verified advantage.
What benefits do product certification bring to my supplement products?
The value of product certification depends on your business.
For brand owners, product certification reduces risks related to product quality and streamlines market access with retailers seeking high-quality suppliers. Product certification provides meaningful differentiation from competitors, especially in high value, high risk product categories with a history of adulteration and poor-quality ingredients, subject to heightened scrutiny by retailers and consumers.
Product Certification enables credible, evidence-based claims and enhances product positioning through the use of certification marks and claims. It significantly reduces business risks arising from product failure, recalls, claims disputes, or consumer complaints. It is a strong and fact-based differentiation that marketing teams can leverage in telling a more convincing brand story.
For manufacturers, it provides independent verification of product integrity and can help identify potential issues. Product certification enhances the value of your white labelling business, by offering pre-certified products ready for the brand label.
Overall, product certification strengthens confidence in both product quality and labelling accuracy.
If you are interested in product certification, Eurofins Assurance offers ANSI/NSF 173 certification for supplements and ingredients. Learn more about the programme here.
For foundational compliance, we also offer accredited GMP certification to 21 CFR 111/117 or NSF/ANSI 455-2. Contact us to get a quote anytime!