Evolutionary vs. Revolutionary: a Snap Shot of the Current Tendencies in Pharmaceutical Industry and the Impact of Process Analytical Technology and Continuous Manufacturing Processes

Abstract

Food and Drug Administration (FDA) challenges the pharmaceutical industry to innovate itself and introduce ever higher quality standards through the use of technology. Development of continuous manufacturing systems and integration of Process Analytical Technology (PAT) applications are poised to introduce revolutionary innovation to the pharmaceutical industry with joint collaborations from equipment manufactures and the academia. Key Terms ⎯ Chemometric Models, Mechanistic Model, Quality by Design, Statistical Process Control.