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Supplier qualification is an element in the U.S. current Good Manufacturing Practice regulation for dietary supplements (21 CFR Part 111). Proper supplier qualification across the dietary supplement industry is critical for maintaining integrity of the supply chain and reducing or preventing economically motivated adulteration. To assist with supplier qualification activities, the SIDI Work Group developed a series of voluntary guidelines to serve as resources for the dietary supplement industry.

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VOLUNTARY GUIDELINE:

Dietary Supplement Component Supplier Qualification

The SIDI Work Group’s third voluntary guideline titled “Dietary Supplement Component Supplier Qualification” is now available as an open access tool for the dietary supplement industry. This voluntary guideline aims to assist manufacturers of dietary supplements (or other users of dietary supplement components) with compliance with the dietary supplement cGMP requirements (21 CFR Part 111.75). Specifically, it provides an outline to guide companies with the development of risk-based supplier qualification programs that may be used to help assess the reliability of component suppliers’ Certificates of Analysis and may assist the user in establishing an appropriate testing routine for incoming components. This Supplier Qualification Guideline follows the SIDI Work Group’s previous voluntary guidelines for the dietary supplement industry: the Certificate of Analysis Guideline and the SIDI^TM Protocol.

DISCLAIMER: These voluntary Guidelines are for information purposes only and intended to assist users with compliance with the cGMPs for Dietary Supplements, 21 C.F.R. § 111. The Guidelines should not be utilized as a substitute for compliance with all applicable laws and regulations. The Authors make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, or suitability of the Guidelines for any purpose. By use of these resources, the user agrees not to hold the authors liable or responsible for the user’s compliance with all applicable laws and regulations. CLICK HERE TO READ FULL DISCLAIMER.