The regulatory landscape for dietary supplements has been changing at light speed. Many small companies still struggle to fully implement dietary supplement GMPs, first published in 2007 (21 CFR Part 111). cGMP regulations for food were revised in 2015 (21 CFR Part 117), exempting finished dietary supplements covered under part 111 but now encompassing dietary ingredients as foods. Dietary supplement GMPs share many similarities with pharmaceutical GMPs, including personnel training, material control, processing controls, complaint handling, but have significant differences related to testing, auditing, and validation, for example. It is generally expected that dietary supplement manufacturers will look to the established experience and history in pharmaceuticals to build appropriate quality systems which will help assure the overall quality of the dietary supplements they manufacture—including identity, purity, strength, and composition. Manufacturers are obligated to know how suppliers and contractors comply with regulations so they can assess whether to approve and release the product for sale. In addition, food safety regulations—primarily the FDA Food Safety Modernization Act of 2011 (FSMA) published in 2015—also encompass dietary supplements and dietary ingredients. Numerous rules have been implemented to support FSMA. Dietary supplement manufacturers need to have a thorough understanding of the entire supply chain, including foreign suppliers of dietary ingredients (under the Foreign Supplier Verification Program). Dietary ingredient manufacturers need to assess their operations for potential manufacturing hazards and control points (Hazard Analysis and Critical Control Points), and implement steps to prevent Intentional Adulteration.
Jeiven can assist dietary supplement manufacturers of all sizes. We can conduct internal audits to identify gaps in your procedures that may expose you to regulatory risk. We can propose new procedures or procedure modifications that will address any ‘hot spots.’ We can outline control processes that are appropriate for the size and scope of your organization. If desired, we can help draft the procedures using your SOP template and format.
Jeiven can also assist your supplier qualification efforts by conducting supplier audits on your behalf. You will receive a thorough audit report detailing the operations of your supplier and identifying any gaps in compliance. If desired, we can assist in remediation activities resulting from audit observations.