PAT Application and Validation of Online Particle Sizing Measurement for Controlling a Critical Quality Attribute
Oct 18, 2011
Kevin J. Bittorf
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...
