The FDA regulates both finished dietary supplement products and dietary ingredients. Manufacturing of these products is regulated under 21 CFR Part 111 – Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) or 21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. In addition, dietary supplements and dietary ingredients are subject to the Food Safety Modernization Act (FSMA).
Audits are required to ensure that your products are manufactured and distributed in compliance with the applicable regulations. A typical audit includes a plant tour, an evaluation of the organization’s GMP controls (including overall quality systems, personnel, equipment/utensils, production and process controls, sanitary operations, laboratory controls, warehousing, etc.), and a review of appropriate documentation (including training records, batch records, test results, inventory management, Hazard Analysis and Critical Control Point [HACCP] assessments, Foreign Supplier Verification Program (FSVP) assessments, etc.). The audit allows a thorough assessment of compliance with the standards set forth in 21 CFR Part 111 and 21 CFR Part 117.
We can conduct:
- Internal audits of dietary supplement manufacturers, packagers, labelers, warehouses, and distribution centers
- Audits of Contract Manufacturer Organizations (CMOs) that produce dietary supplement products on behalf of your company
- Audits of dietary ingredient manufacturers, importers, or distributors
- Reviews of supplier qualification programs, assessing compliance with key rules implementing FSMA, including FSVP and Mitigation Strategies Against Intentional Adulteration
We can assist with post-audit remediation, if requested, including recommending and drafting SOPs for internal use, and can assist in setting up CAPA programs and resolving associated issues, or review CAPA plans and timelines.
We can provide customized on-site training, click here to learn more.