Abstract
According to FDA guidance, PAT (Process Analytical Technology) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i. e., during processing) of critical quality and preformance attributes of raw and in-process materials and processes. A desired goal of the PAT framework is to design and develop well understood processes that will consistently ensure a predefined quality at the end of the manufacturing process. PAT tools can be categorized according to the following: 1) Multivariate tools for design, data acquisition and analysis, 2) Process analyzers, 3) Process control tools, 4) Continuous improvement and knowledge management tools.
In this article, process analyzers are introduced and discussed with their actual application under the recognition of PAT as a system.
