In 2004, the FDA issued the process analytical technology (PAT) framework guidance in order to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance.

This framework has been defined by the agency as 'a system for designing, analysing, and controlling manufacturing through timely measurements (during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.'

The PAT framework propounds process scientific understanding in order to facilitate sound innovation and risk-based decision making.

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