(657c) Scientific and Regulatory Considerations for Developing the Control Strategy of a Continuous Manufacturing Process

Advances in manufacturing technology over the last decade have provided the pharmaceutical industry opportunities for adopting innovative ways to develop flexible, efficient and robust processes. In recent years, continuous manufacturing has emerged as a new technology for the manufacture of pharmaceuticals. Compared to traditional batch process, continuous manufacturing has various advantages, such as, shorter processing times, smaller facility footprint, etc. On the other hand, it has unique elements that lead to uncertainty on how to implement a continuous process within the current regulatory framework. The Food and Drug Administration supports the adoption of innovative technology and is communicating with pharmaceutical companies and academia to facilitate the development of continuous processes. This presentation will discuss several scientific, current good manufacturing practice (CGMP) and regulatory considerations for developing the control strategy of a continuous manufacturing process.