Supplier Qualification – Is your Supplier Qualified?

March 18, 2013 By

Supplier qualification is a requirement of the regulations, as set out by 21 CFR part 111.75. Setting up a proper supplier qualification program is an essential step in maintaining dietary supplement ingredient quality and integrity.

Supplier qualification is an important step in assuring the quality of a product and justifying a reduced testing program. A supplier qualification program is also required for compliance with the dietary supplement cGMPs. According to the dietary supplement cGMP’s 21 CFR part 111 section 111.75 (2)(ii) you must qualify your supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results. In establishing a supplier qualification program you are also required to maintain documentation of how you qualified the supplier and periodically re-confirm the supplier’s certificate of analysis. It is up to your quality control personnel to review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.

The regulations do not provide much instruction on how to qualify a supplier, and so the SIDI working group has taken this task upon themselves to publish a voluntary guidance document entitled “Dietary Supplement Component Supplier Qualification, A Voluntary Guideline” released on January 2013. This guidance document replaces the last version dated April 2012. The SIDI Work Group, is a collaboration of three dietary supplement trade associations and expert volunteer member company representatives. The trade associations include: the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA). The guidance document is based on the principles of risk assessment and the sections covered include pre-assessment criteria, supplier capability and audit assessment, certificate of analysis confirmation, supplier/comment re-qualification, and supplier/component disqualification

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