Process and Analytical Technology (PAT) Initiative

Process and Analytical Technology (PAT) Initiative

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.

Process Analytical Technology tools:
There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. In the PAT framework, these tools can be categorized as:
Multivariate data acquisition and analysis tools
Modern process analyzers or process analytical chemistry tools
Process and endpoint monitoring and control tools
Continuous improvement and knowledge management tools
An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance. more....Process and Analytical Technology (PAT) Initiative

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