Presented by Tara Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services
The COVID-19 pandemic is causing major disruptions of business and the global supply chain across many industries including public health products that are regulated by the FDA. This means there is an additional challenge for these companies to ensure that these disruptions do not result in a failure to comply with required regulations. Dietary supplement companies must be in compliance with Current Good Manufacturing Practices (cGMPs) as dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. In 21 CFR 111 there are detailed requirements for the receipt, testing, and use of raw materials (dietary ingredients and components), and many of these are sourced from foreign suppliers. When foreign suppliers are used there are also modified Foreign Supplier Verification Program (FSVP) requirements that may apply in order to comply with the Food Safety Modernization Act (FSMA).
Raw materials must have an established specification and testing must be performed to determine whether those specifications have been met upon the receipt of every shipment of the material per 21 CFR 111.70(b) and 111.75(a). Testing from the supplier of the material, represented on the Certificate of Analysis (COA), cannot be relied upon to demonstrate that this specification has been met unless the supplier has first been Qualified via a 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 Certificate of Analysis (COA) Confirmation Testing;
- On-Site Supplier Facility Audit; and
- Re-Qualification of Supplier periodically
With a foreign supplier, compliance with FSVP must also be incorporated into this qualification.
Given the current COVID-19 outbreak that has resulted in numerous travel bans and restrictions all over the world, it may not be possible to receive raw materials from previously Qualified suppliers; and the performance of an on-site supplier facility audit to qualify alternative suppliers cannot be accomplished either.
Join EAS Consulting Group’s Tara Lin Couch, Ph.D., Senior Director of Dietary Supplement and Tobacco Services, for a deeper dive into how to conduct a Supplier Qualification Program that also incorporates FSVP requirements as it applies to dietary supplements. Learn the crucial steps to compliance, including considerations during the COVID-19 pandemic, to maintain the safety of your products, your employees and the consumer.
About the Presenter
Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.
Tara serves on various industry committees for the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), and the Food, Drug Law Institute (FDLI). She is also active in the American Herbal Products Association (AHPA).