(375a) A Regulatory Perspective On the Current and Future State of Pharmaceutical Manufacturing

For almost one decade, the US FDA has been encouraging pharmaceutical manufacturers to modernize their manufacturing processes, improve their process and product understanding, and adopt state of the art quality management systems. These efforts have spurred great advances in science and risk based approach for pharmaceutical development and manufacturing such as Quality by Design (QbD) and Process Analytical Technology (PAT). QbD has become a development standard in many innovator pharmaceutical companies and increasingly is being adopted by biotech and generic firms.

This presentation will cover a brief background in FDA’s quality initiatives and QbD principles as outlined in International Conference on Harmonization (ICH) guidances, ICH Q8(R) “Pharmaceutical Development,” ICH Q9 on “Quality Risk Management,” and ICH Q10 on “Pharmaceutical Quality Systems.” Examples will be presented of advanced pharmaceutical manufacturing currently being practiced. Finally, future directions in advanced pharmaceutical manufacturing will be discussed, including multivariate approaches to batch “process signatures” and continuous manufacturing.