abstract:Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).
A high-shear mixer is mostly used for the wet-granulation. AppliedProcessAnalyticalTechnology(PAT) andstatisticaltoolsof granulation are dominating the kingdom ofwet-granulation.