SIDI Work Group releases third GMP compliance guideline

SIDI Work Group releases third GMP compliance guideline

New guideline is designed to assist industry in supply chain integrity, which is a requirement for complying with cGMPs.

The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, today announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline (SQG). The new guideline is designed to assist industry in supply chain integrity, which is a requirement for complying with current Good Manufacturing Practices (cGMPs). The SIDI (Standardized Information on Dietary Ingredients) Work Group comprises three of the supplement industry’s trade associations—the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA)—and dietary supplement manufacturers and ingredient suppliers with an interest in increasing the industry’s self-regulatory efforts.

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. 

“The dietary supplement industry as a whole needs to improve its track record on cGMP compliance, said Duffy MacKay, N.D., chair, SIDI Work Group Executive Committee, and vice president, scientific and regulatory affairs, 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. We expect this guideline will be useful to all companies, regardless of their size. As FDA 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.”

The SIDI Work Group, which issued a draft of the SQG in April for industry comment, finalized the guideline after taking stakeholders’ comments into consideration. The SQG is the third voluntary guideline developed by the SIDI Work Group, and complements the earlier guidelines—the SIDI Protocol and the CoA (Certificate of Analysis) Guideline.

The SIDI Work Group website provides access to all of the guidelines. There is no charge to download the documents once the user completes the free on-site registration process.



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