A Strategy of Using Mechanistic Understanding for Continuous Quality Verification

Quality by Design is a FDA initiative to mitigate quality risk of manufacturing through process understanding and control. In this presentation we will describe a strategy of combining risk assessment on key process steps, designing of monitoring tools to gain process insight, development of mechanistic model based on process physics, and verification through experimental design. Demonstrated by a case study of functional coating, we believe that such a strategy may be implemented. It is possible to acquire the benefits of fast scale up, streamlined technology transfer, and continuous quality verification with the support of regulatory flexibility.