More Predictable Post-Approval Change Policy on Horizon

Abstract

In the works formally since 2014, the Q12 guideline is expected to provide flexible oversight of post-approval changes with reduced regulatory reporting for manufacturers able to demonstrate enhanced knowledge about product, manufacturing process, and analytical procedures, as provided by a company's product quality system (PQS). A key feature of Q12 outlines how manufacturers should define those established conditions (ECs) that are considered necessary to assure product quality. [...]a change to an EC would require a regulatory submission, explained Chikako Torigoe, biologist in the office of the director of FDA's Center for Biologics Evaluation and Research (CBER). Encouraging improvement Despite the challenges, manufacturers hope to move forward with Q12 as more products are tested, produced, and distributed in multiple regions, creating complex supply chains that trigger diverse testing requirements and inspection processes.