The FDA’s Pharmaceutical Quality for the 21st Century initiative began in 2002 with the intention to modernize the agency’s regulation of pharmaceutical quality. It has further evolved to capture the larger issue of product quality, with cGMPs being an important tool toward improving overall product quality. The FDA’s vision for quality is a “maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
Thomas O’Connor, Office of Pharmaceutical Quality, noted in his presentation at IFPAC 2016 that, “to fully achieve this vision constitutes moving toward smart manufacturing — not just a single facility but an entire enterprise.” Smart manufacturing comprises real-time understanding, reasoning, planning and management of all aspects of the manufacturing enterprise, and this is often facilitated by use of advanced sensor-based analytics, modeling and simulation. These advanced process control (APC) and optimization tools are key mechanisms to implement smart, enterprise-wide decisions.
Progress has been made over the past decade that has laid the foundation for the adoption of process systems engineering tools to accelerate modernization. For example, the adoption of PAT, QbD and plant-wide technology systems. Adoption of advanced process control tools can deliver superior quality performance, long-term cost reduction and efficiency improvement, but obstacles still exist. Barriers include a lack of understanding of the approach, a need for demonstration of benefits and a lack of models to predict end quality.
Continuous manufacturing is a potential driving force for this APC adoption. The continuous manufacturing method employs the concepts of continuous flow, end-to-end integration, a systems approach, and an integrated control strategy. Continuous manufacturing, and the advanced process control tools that support it, play a key role in future development for smart manufacturing.
The FDA has several ongoing research initiatives in the APC space related to continuous manufacturing.The agency continues to be interested in developing collaborations to address barriers. For more information, contact the Emerging Technology Team at: CDER-ETT@fda.hhs.gov.
Editor’s note: Thomas O’Connor’s presentation reflected the views of the author and should not be construed to represent FDA’s views or policies.