US Dietary Supplement cGMPs: Ingredient Supplier Qualification

Abstract

Published by the US Food and Drug Administration in June 2007, current good manufacturing practices (cGMPs) for dietary supplements (21 CFR Part 111) are now mandatory for all firms that manufacture, package, label, or hold dietary supplements for sale in the United States. Ingredient supplier qualification remains one of the most critical, yet least understood, aspects of the regulation. The increasingly global supply chain and multiple instances of supply chain failures that have led to adverse consequences have elevated the need for proper supplier qualification. However, FDA’s expectations for supplier qualification remain unclear, and there is little knowledge of what constitutes industry best practices. Following the precedent set by other FDA-regulated industries, the dietary supplement industry has formed a consortium to address the knowledge and practice gap regarding supplier qualification. The group has developed a series of voluntary guidelines to assist ingredient suppliers and dietary supplement manufacturers with the qualification process. These guidelines, some of which are still under development, are intended to serve as tools or templates on which a firm’s own qualification program or standard operating procedures can be based. It is hoped that these guidelines will serve as the basis for future FDA guidance or rule making, should the need arise.