The level of impurities is a critical attribute because its impact the safety and quality of pharmaceutical finished products; therefore, control strategies for impurities must be established to ensure new unintended impurity is adequately evaluated, reported, and qualified. However, after receiving the approval of commercial products, changes to the products will be necessary and methods may need to be updated with new changes. ICH Q12 provides guidance on the lifecycle management of the products; thus, a formal change control program is essential to monitor impurities. In addition, multiple manufacturers may gain approvals to market the same product. Compendial monographs may be available, including a list of approved impurities depending on their processes or suppliers. However, different manufacturers may have different strategies for their organic impurities; and changes may cause different impurity increases unintendedly. This session will discuss the development of impurities controls after approval, key information to be considered when working with generic products or over-the-counter products and the responsibility of the manufacturers to evaluate the impurities that may present in their API or finished products.