Active Process Control in Pharmaceutical Continuous Manufacturing – The Quality by Control (QbC) Paradigm

Pharmaceutical continuous manufacturing is essentially in a steady state, or in a state of control, in process operation, by which variations in critical material/product properties and process parameters can be monitored and controlled in real time within an acceptable range that enables the comprehensive implementation of the Quality by Design (QbD) principles. This advantage, facilitated by the implementation of active process control, has recently been evolving and nurturing a new paradigm of Quality by Control (QbC) in pharmaceutical continuous manufacturing. The concept of QbC has acquired acknowledgement in recent applications in pharmaceutical continuous manufacturing and bioprocessing.