(299f) Quality-by-Design (QbD): Integration of Real-Time PAT Process Monitoring and off-Line Product Characterization to Explore the Linkage Between a Pharmaceutical Process and Product

Wu, H., FDA
Khan, M. A., Food and Drug Administratin

Real-time PAT process monitoring offers an unprecedented opportunity to observe what is going on inside the process and thus provides a window to study the process dynamics. Off-line characterization of the product could provide information about the physical/chemical properties of the product. Although from a process engineering perspective, the effects of process conditions on the product quality exist anyway for any process, the linkage between the process conditions and product quality attributes may not be obvious or easily appreciable. The lacking of easily appreciable linkage may present a barrier for the implementation of PAT and QbD in the pharmaceutical industry. In this work, several case studies will be presented to explore this linkage and its regulatory utilities in the pharmaceutical CMC area.