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Process Analytical Technology (PAT)

New approaches to manufacturing control and quality assurance yield considerable potential for improvement in product quality, efficiency, safety and documentation. As a part of its risk-based approach to current Good Manufacturing Practices (cGMPs) for the 21st Century, the US Food and Drug Administration (FDA) established a regulatory framework that supports manufacturing innovation and helps companies build quality into the manufacturing process.

The Process Analytical Technology initiative is one such proactive approach to improve quality assurance, efficiency and effectiveness of product manufacturing. It involves a strategy that helps to better understand processes and to continually improve product quality by reducing process variability. Details on the implementation of PAT are described in the PAT White Paper.

PAT requires a considerable shift in organizational structure and integrates different scientific, manufacturing and project management disciplines. For this reason, manufacturers typically look to implement PAT programs in phases, starting with a specific project for a product or production line and then gradually expanding to other areas.

The global business, compliance and quality consulting, engineering, and support services of Rockwell Automation help ensure that integrated PAT solutions can be implemented throughout the organization. This results in ease of validation and maintenance supporting long-lived and sustainable financial return.