US Dietary Supplement cGMPs: Ingredient Supplier Qualification
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US Dietary Supplement cGMPs: Ingredient Supplier Qualification
Andrew Shoo, PhD Senior Vice President. Scientific and Reeulatorv , Affairs, Council for Responsible Nutrition. Washington. DC < ,
Published by the US Food and Drug Administration in June 2007, current good manufacturing practices (cGMPs) for dietary supplements (2 I CFR Part I I I) 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 ofthe most critical, yet least understood, aspects of the regulation. The increasingly global supply chain and multiple instances ofsupply chain failures that have led to adverse conseauences 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
Key Words Dietary supplements; Good manufacturing practices; Supplier qualification
Correspondence Address Andrew Shao. PhD. Senior Vice President. Scientific and Regulatory Afairs. Council for Responsible Nutrition. Washington, DC 20036 (email: ashao @crnusa. org). Based on the proceedings of the 46th annual Drug Information Association meeting. Washington. DC. June 14,2010.
INTRODUCTION In the United States, current good manufacturing practices (cGMPs) for dietary supplements were finally promulgated by the Food and Drug Administration in June 2007 ( l ) ,13 years after being authorized in the Dietary Supplement Health and Education Act (DSHEA) of 1994 (2). Among the numerous provisions cited in the 208-page codified regulation is a requirement that dietary supplement manufacturers qualify their raw material suppliers (and their ingredients) in order to rely on the suppliers’ certificates of analysis (COAs). Proper ingredient supplier qualification is not only a requirement for compliance with the cGMPs, it is essential for avoiding supply chain failures and maintaining traceability of products, especially in today’s global supply chain. However, the industry’s supplier qualification practices vary greatly, and FDA’s expectations as to what constitutes proper qualifications are unclear. Additional requirements beyond cGMPs concerning supply chain integrity have been proposed in food safety legislation (3), which adds another layer
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 sewe 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 sewe as the basis for fiture FDA guidance or rule making, should the need arise.
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