PharmTech Poll Results: How do you define ‘PAT,’ or ‘Process Analytical Technology’?
Thanks to all of you who participated in our poll! Here are a few of your answers, followed by the definition of ‘process analytical technology ’ given by FDA.
1. “I believe that PAT is well-defined in their Guidance document in IV. PAT Framework, ‘a system for designing, analyzing, and controlling manufacturing ... with the goal of assuring final product quality. Analyzing is not just lab analysis but also includes statistical analysis of the data.’”
2. “PAT means incorporating analytical steps into each stage of the manufacturing process and using the results to evaluate and control the process in real time.”
According to FDA
FDA defines process analytical technology in its Guidance for Industry, as:
“Process Analytical Technology is: 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.
“It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.” The guidance is available here.
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