(325e) Role of Real-Time Monitoring Tools and Chemometrics for Development and Maintenance of Pharmaceutical Design Space

Wu, H., FDA

Recent pharmaceutical quality initiatives (PAT, ICH Q8, Q8R1, Q9, and Q10) have highlighted the necessity and critical importance of using PAT tools and QbD principles for pharmaceutical development, process understanding, and design space development. Based on the screening results of risk analysis and design of experiments (DOE), real-time process monitoring tools such as vibration spectroscopic technologies could enable real time data acquisition for both critical process variables and key quality attributes. Chemometrics tools could help to extract critical and essential information from the process and product data. That information, once being integrated with the process and product engineering knowledge as well as control practice, could form the scientific basis of the design space concept. In this talk, several case studies based on FDA research activities will be presented to discuss the utilities of real-time monitoring tools and chemometrics for development and maintenance of pharmaceutical QbD design space.