Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application—including model life-cycle management—in combination with continuous manufacturing for small and large molecules, with the goal of proposing strategies to resolve each challenge.

• Janssen Supply Group LLC

• St Louis College of Pharmacy

• University of Maryland

• GSK

• Körber Pharma Austria

• HDR COMPANY LLC

• PAT
• Regulatory

1. pat
2. quality
3. Quality assurance.
4. regulatory