USP Verification Services for Qualifying Suppliers of Dietary Supplement Components to Meet the Requirements of 21 CFR §111.75(a)(2)(ii)(A)

From Dietary Supplements e-Newsletter - September 2009

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John Atwater, USP

The dietary supplement CGMPs1 provide details for what dietary supplement manufacturers must do to determine whether their components meet specifications. "Component" means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the product. Section 111.75(a)(2)(ii)(A) of the dietary supplement CGMPs requires dietary supplement manufacturers that rely on a Certificate of Analysis from the supplier of the component to determine whether the component meets specifications, to qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations. However, the CGMPs offer few details regarding the steps needed to qualify suppliers.

Some dietary supplement manufacturers that have sufficient and appropriate resources have a well-established supplier qualification program to help minimize the risks associated with their supply of components for manufacturing dietary supplements. Other dietary supplement manufacturers lack sufficient resources not only to establish an effective supplier qualification program, but also to conduct full specification testing to ensure the identity, composition, strength, quality, and purity of their components. Fortunately, the USP Verification Programs offer a solution.

USP Verification Programs have three voluntary auditing and testing programs devoted to dietary supplements. The USP Dietary Supplement Verification Program was launched in 2001 to provide a mechanism by which dietary supplement manufacturers can ascertain the quality of their products. In 2004, USP launched the Dietary Ingredient Verification Program to help dietary ingredient manufacturers ensure the production of quality dietary ingredients. A similar program for excipients was launched in 2006, under USP's Pharmaceutical Ingredient Verification Program. These latter two programs can assist dietary supplement manufactures in qualifying their suppliers of components, namely dietary ingredients and excipients.

USP verifies components submitted to its verification programs through a multiple-step process: audit of manufacturers' quality systems for compliance with GMPs; review of manufacturing and quality control documentation; and laboratory evaluation of component samples from selected lots for compliance with label claims and USP program requirements. Components that already have been verified by USP are also tested to ensure continued compliance with USP's program requirements. USP tests are carried out in accordance with USP's official or proposed standards for dietary ingredients and excipients, and also against international guidelines where applicable. USP awards use of the USP Ingredient Verified Mark for dietary ingredients and the USP Pharmaceutical Ingredient Verified Mark for excipients, and issues a verification certificate for components that meet its rigorous program requirements.

Components bearing the USP Verified Mark provide dietary supplement manufacturers with a means by which to qualify their suppliers and the assurance that the components they are purchasing are consistent in quality from batch to batch; meet label or certificate of analysis claims for identity, strength, purity, and quality; are prepared in accordance with accepted manufacturing processes; and meet requirements for acceptable limits of contamination. More information on USP's Verification Services can be obtained at www.uspverified.org.

¹ Food and Drug Administration. 21 CFR Sec. 111.75: What must you do to determine whether specifications are met? In: Code of Federal Regulations. Washington, DC: National Archives and Records Administration. April 1, 2009. Title 21, Volume 2, Pages 239-240. Available at: http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr111.70.pdf.