How robust is your dietary ingredient specification, testing and supplier qualification program?
The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require the establishment of component (Dietary Ingredient) specifications and then testing must be performed to determine whether those specifications have been met upon the receipt of every shipment of the material.
Per 21 CFR 111.75(a)(2)(ii) testing from a material supplier, represented on the Certificate of Analysis (COA), cannot be relied upon unless the supplier has first been qualified via a Supplier Qualification Program. That program be approved by the Quality Unit. There may also be FSVP requirements to contend with under FSMA if the supplier is outside of the U.S.
Lean the steps to a Supplier Qualification Program and how to develop and implement one that is both efficient and meets FDA’s expectations.
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About the presenter
Aisha Siddiqui is an Independent Consultant with EAS Consulting Group with significant experience and knowledge of regulatory requirements, including cGMPs, for foods, cosmetics, and dietary supplements in both the US & EU market. She has particular expertise with contractual relationships between Own Label Distributors, contract manufacturers, co-packers, and contract laboratories. She is also well-versed in the challenges of the global supply chain, having been responsible for all supplier qualification activities that included ensuring compliance to the Food Safety Modernization Act (FSMA) and the Foreign Supplier Verification Program (FSVP) rule, as well as various regulations including FDA 21 CFR 117, 111, 210/211, and 113/114; and EU regulations dictated in (EC) No 178/2002, (EC) No 852/2004, (EC) No 1223/2009; FSA standards; and ISO 22716:2007 standards. Moreover, Ms. Siddiqui excels at project management and the development and implementation of quality systems. As a consultant, Ms. Siddiqui assists with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical and compliant with FDA regulations. She also performs gap analyses, and contractor/supplier audits.