Chapter 8 - Process analytical technology (PAT) tools: Uses in pharmaceutical manufacturing

Abstract

Process analytical technologies (PAT) have been mostly applied for designing, analyzing and controlling various processes functional during product manufacturing. These technologies are utilized for providing necessary informations about various parameters that could significantly affect different critical quality attributes (CQA). PAT is efficiently used to examine the raw material and final product quality, both physically and chemically, leading to reduction in engineering costs and thus improves the manufacturing sector of the pharmaceutical or chemical industries. PAT have provided effective tools which have improved the operative control and amenability, so resulted in continuous and instantaneous quality improvement of products. PAT includes a transferal from analyzing the quality of product development to the quality of final products by examining at various intermediate (in- or out-line processing)stages. As considered for industrial sector, this technique has emerged as a novel tool and numerous work is going on at academic and industrial level. Herein, we have explored the various aspects of PAT, including significant role of QbD (Quality-by-Design), in various industrial processes and manufacturing aspects.