Process Analytical Technologies (PAT) and Quality by Design (QbD)

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Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurement of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality.

The Quality by Design (QbD) framework concerns designing and developing processes that can consistently ensure a predefined quality, resulting in real-time release of products.