Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations. Similar to batch manufacturing, CM requires a comprehensive and holistic control strategy throughout the product life cycle to ensure, in a reproducible and consistent manner, the intended product quality at the time of release and throughout the product’s shelf life. A control strategy developed using a scienceand risk-based approach will ensure that reproducible product quality is achieved throughout the product life cycle, while maintaining the efficiency, robustness, and fl exibility that CM has to offer.

• Merck & Co., Inc.
• Rutgers, The State University of New Jersey
• Pfizer Inc

• PAT
• Control

1. Control
2. Control strategy
3. disturbances
4. Other
5. pat
6. RTRT
7. Solid oral dosage