Smart Manufacturing, FDA’s Vision for Quality

Feb. 26, 2016
Continuous manufacturing, and the advanced process control tools that support it, play a key role in future development for smart manufacturing

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: [email protected].

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.

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'