ABSTRACT
In the biotechnology industry, there is a tendency that process analytical technology (PAT) primarily concerns implementation of sophisticated analytical technologies and advanced feedback controls. It is, therefore, worthwhile to revisit the U.S. Food and Drug Administration (FDA) definition of PAT (US FDA 2004): “The Agency considers PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.”
