The PAT Framework
The idea behind the PAT framework is that a well-understood process leads to a predefined final product quality that reduces regulatory concerns and increases process efficiency in the least amount of time with the least operational costs.
With PAT, quality is built into the process design and is not tested into the products. This is how PAT opens the door for Quality by Design (QbD) strategies, paving the path to lean manufacturing principles.
Researchers identify and explain the sources of variability, the process manages the variability, and the scientists can accurately and reliably predict product quality over the design space, critical process parameters (CPPs), and manufacturing conditions.