In accordance with ICH Q8/9/10 and the FDA QbD initiative, companies are adding more and more PAT equipment, installing more sophisticated control systems, and moving to real-time release. Throughout this process, many questions have come to light. How is PAT justified for controlling quality attributes? How is PAT incorporated into the overall control strategy? What is needed for to validate a PAT system? These questions will be answered in a case study of using PAT to monitor and control the critical quality attribute of particle size in a production setting.
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