ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Process Analytical Technology (PAT)

For the purpose of this guidance, PAT is considered to be a system for dsigning, 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.

Publication Source: GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach

Publication Date: 2010

Process Analytical Technology (PAT)

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.

See also: PAT (Process Analytical Technology)

Process Analytical Technology (PAT)

Tools and systems that utilize real-time measurements, or rapid measurements. It may be used during development or manufacturing of pharmaceuticals to monitor and/or control process parameters.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Process Analytical Technology (PAT)

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.

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

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