Enable A Data-Driven Quality Culture Throughout Pharmaceutical Organizations

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, 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”. The PAT framework propounds process scientific understanding in order to facilitate sound innovation and risk-based decision making. The tools and approaches described within the PAT guidance are expected to promote a pharmaceutical cultural change and to encourage the development of more efficient pharmaceutical manufacturing processes. This in turn, should increase the effectiveness of the health care system (from the patient’s perspective). Besides innovation and process understanding, the PAT framework (and tools) can be used in support of post approval changes and to justify flexible regulatory routes such as demonstrating process validation through continuous quality assurance.