(509a) Regulatory Science Perspective on Continuous Manufacturing

Authors: 
Cruz, C. N., U.S. Food and Drug Administration

The continuous manufacturing of pharmaceutical drug products is gaining momentum within the industry. The successful implementation of continuous manufacturing represents the culmination of innovative quality and regulatory approaches from the previous decade, including PAT, increased product and process understanding, and advanced control strategies.  The FDA’s Office of Pharmaceutical Quality supports the development and implementation of control strategies that lead to increased quality assurance and availability of medicines to the public.  This presentation will address the control strategy considerations for implementation of a continuous manufacturing process, focusing on assurance of quality aspects. The discussion will include concepts such as science-based justification for material traceability, sampling frequency and throughput/run time.   The importance of understanding failure modes and implementing of controls at appropriate levels will be highlighted with emphasis on increased process understanding and demonstration of a state of control. In conclusion, design and operation of a continuous manufacturing process is based on science and engineering principles, but a control strategy that ensures product quality and consistency is the key to addressing the regulatory challenges for this technology.