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Process Analytical Technology

The FDA’s definition of 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.” The FDA adds, “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 US FDA has listed tools that fit within the PAT framework…
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.

EmsPT has undertaken a complete analysis of what this means to vendors and integrators. The findings obtained show that currently available tools that deliver this functionality, in real-world application exist and are part of EmsPT’s deliverable and its normal approach.

These are:
• Data Acquisition (hardware, connectivity and historisation)
• Laboratory Interfaces for real-time data systems
• Production Events logging
• Real time reports, web enabled and dashboards
• Microsoft Office integration and suite connectivity.

EmsPT can demonstrate effective proposals to implement the PAT framework can be resourced here and now – with just one added ingredient – know-how – EmsPT’s expertise in the validated systems allows effective and experience driven solutions to be developed from these tools.

All industries can reduce risk by adopting appropriate steps and procedures using PAT methodology. For effective PAT, here and now, contact EmsPT.