Certificate of Analysis for Dietary Supplement Components

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April 2010

This is a Standardized Information on Dietary Ingredients (SIDI) Work Group document.

This document serves as a guideline for the preparation by suppliers and appropriate use by their customers of a Certificate of Analysis (COA) for Dietary Supplement Components. The goal is to standardize the content and format of COAs for dietary supplement components and to clearly define the roles and responsibilities for component suppliers, distributors, dietary supplement manufacturers, and other users who need to meet the dietary supplement current Good Manufacturing Practice (cGMP) requirements of the US FDA, that is, 21 CFR Part 1112. The detailed definitions and thorough explanations are intended to establish uniform considerations regarding COAs for component suppliers and dietary supplement manufacturers. It is hoped that, with use of this guideline as a foundation for mutual understanding, greater assurance of regulatory compliance will be achieved for components used in the manufacture of dietary supplement products.