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 the supplier of the material, represented on the Certificate of Analysis (COA), cannot be relied upon unless the supplier has first been Qualified via a Supplier Qualification Program. The regulations also require that this Supplier Qualification Program be reviewed and approved by the Quality Unit. When foreign suppliers are used there are additional modified Foreign Supplier Verification Program (FSVP) requirements that may apply in order to comply with the Food Safety Modernization Act (FSMA) that must also be provided for in the Supplier Qualification Program. A Supplier Qualification Program is a multi-step, risk-based process that includes:
• Supplier Documentation Audit via a Supplier Qualification Questionnaire;
• Supplier Risk Assessment;
• Supplier Certificate of Analysis (COA) Confirmation Testing;
• On-Site Supplier Facility Audit; and
• Re-Qualification of Supplier periodically
Learn how to develop and implement a Supplier Qualification program that is efficient, but still meets the expectations of the FDA.