Application Note: Process Analytical Technology Approaches to Risk Reduction through Quality by Design

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on an understanding of the scientific and engineering principals involved and identification of the variables which affect product quality. The PAT initiative is consistent with the current FDA belief that quality cannot be tested into products, but should be built-in or by design. This SSCI Application Note reviews PAT approaches to process control, particle size, controlling polymorphic form, content uniformity, and drying.

Published by: SSCI Inc.