Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals—Promise, Practice, and Challenges

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The “vision” underlying the use of process analytical technologies (PATs) in the manufacture of pharmaceuticals has been articulated as “…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.”