CMC Workshop

A major element of the new paradigm in pharmaceutical quality, besides science and risk management, is the life cycle approach as described in ICH Q10. Continuous verification strategies form the basis for handling life cycle maintenance. These strategies can enable continuous improvement and process optimization by continuously collecting information, allowing for better scientific understanding of both process and product. The session will present the regulatory expectation for process validation and process verification. Two drug substance examples, chemical and bio, will highlight the benefit of continuous verification strategies compared to traditional process validation.