(299b) QbD at the Boundary

Quality Risk Assessments (QRA) for API and DP processes are mostly performed independently to examine the chemical or formulation processes themselves in terms of process risk and potential process control strategies. However, many of the process risks in a formulation process can be attributed to the properties of the API. In my talk, I will examine the potential application of QRA's to examine the overall risk across the API-DP boundary.