Dietary supplements Own Label Distributor (OLD) regulatory responsibilities:six critical items and processes

摘要

The dietary supplement industry incorporates a complex supply chain with the use of contract manufacturers, contract packagers, contract laboratories, and separate distribution warehouses all at the direction of the product owner or Own Label Distributor (OLD). Regardless of whether the OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111. The development of critical OLD processes will go a long way to ensure compliance and should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored. It is also highly recommended that a Quality Agreement be established between the OLD and contractors for the assignment of quality responsibilities.