WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.
“The dietary supplement industry as a whole needs to improve its track record on cGMP compliance," stated Duffy MacKay, chair of the SIDI Work Group Executive Committee and VP scientific and regulatory affairs for the Council for Responsible Nutrition [CRN]. “The voluntary guidelines from the SIDI Work Group encourage industry compliance; in particular this newest guideline offers a compliance roadmap so companies can establish methods that will best help them build relationships with the right supplier partners."
Under cGMPs, manufacturers are responsible for qualifying their suppliers if they choose to rely on suppliers’ certificates of analysis. The new guideline outlines a process a dietary supplement manufacturer may use to establish its own ingredient supplier qualification program to assess a supplier’s suitability as a provider of raw materials.
"As [the Food and Drug Administration] increases enforcement efforts on cGMP compliance, it is especially critical that companies rigorously qualify their suppliers, so the agency, as well as consumers, can feel confident that our industry is manufacturing and marketing high quality, safe products," MacKay added.
The SIDI Work Group comprises three of the supplement industry’s trade associations, including the Consumer Healthcare Products Association, CRN and the United Natural Products Alliance. The SQG is the third voluntary guideline developed by the SIDI Work Group, and complements earlier guidelines the SIDI Protocol and the Certificate of Analysis Guideline.
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