April 17, 2012

2 Min Read
SIDI Releases Supplier Qualification Guide

WASHINGTONA manufacturer should prequalify an ingredient supplier by reviewing certificates of analysis (CoAs), regulatory history and self-audit questionnaires, according to new draft voluntary guideline issued by the SIDI Work Group, a dietary supplement industrys self-regulatory coalition.

The Dietary Supplement Component Supplier Qualification Guideline is designed to help manufacturers determine if ingredient suppliers are working under good manufacturing practices (GMPs). Along with more information on pre-assessment criteria, the document offers recommendations on supplier capability/audit assessment, CoA confirmation and supplier/component disqualification.

The SIDI Work Group is requesting comments on the draft voluntary guideline from industry stakeholders, regulators, and other interested parties within a 60-day period, ending June 18.  The SIDI Work Group will consider comments it receives as it finalizes the guideline.

The SIDI Work Group intends for the supplier qualification guideline to be flexible so that it can be applied across the industry, and so that large, medium and small companies will find it a useful tool to support the development of individual company supplier qualification programs," said Duffy MacKay, N.D., chair of the executive committee, SIDI Work Group, and vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN).  A practical aspect of the guideline is the stratification of supplier and component risk, which allows companies to better allocate limited resources during the supplier qualification process."

The SIDI Work Group, formerly known as the Joint SIDI (Standardized Information on Dietary Ingredients) Working Group, is made up of three of the supplement industrys trade associationsthe Consumer Healthcare Products Association (CHPA), CRN and the United Natural Products Alliance (UNPA)and dietary supplement ingredient suppliers and finished product manufacturers with an interest in strengthening the industrys self-regulatory practices.

This draft guideline will mark the third voluntary guideline developed by the SIDI Work Group, and is a companion piece to the earlier  guidelinesthe SIDI Protocol and the CoA Guideline.

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