Senior Director, Tara Couch, Ph.D. was interviewed for an article in Natural Products Insider on COVID-19’s threats to the dietary supplement contract manufacturing relationship. COVID-19 fears, risk of massive recalls and misunderstanding of GMPs underscore the importance of transparency between supplement brands and their contract manufacturers.
ABH recall and COVID-19 threat to contract manufacturing relationships
Question: How do concerns over COVID-19 affect contract manufacturing in 2020?
Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting Group LLC: Raw materials (dietary ingredients and components) 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 cGMPs [current good manufacturing practices] 21 CFR (Code of Federal Regulations) 111.70 and 111.75. Qualified suppliers are preferred suppliers to reduce both testing costs and timelines. A significant disruption in the delivery of materials from qualified suppliers, as is now the case due to COVID-19, presents a serious issue to a contract manufacturer. Alternative suppliers will have to be identified and employed, at least temporarily, and full testing to the entirety of the specification parameters must be performed. If the disruption persists, contract manufacturers will have to assess whether a qualification of the alternative supplier is beneficial. Read More in Natural Products Insider