A Review on Process Analytical Technology as a Driver of Pharmaceutical Manufacturing for the Improvement of Quality while Reducing Costs.

Abstract

Process analytical technology has emerged as a possible game-changing platform in the pharmaceutical business to improve process knowledge while also improving product quality and lowering production costs. This paper outlines the underlying principles of PAT, its application in pharmaceutical manufacturing processes, and the impact on assurance of quality and reduction of cost. Real-time monitoring, multivariate data analysis, and process control strategies are three modules that are computed and integrated with PAT to develop robust and efficient manufacturing processes. A number of case studies and examples have been used to illustrate this relationship between the implementation of PAT and a reduction in variability with an improvement in process control and consistency of the product, which finally realizes million-dollar savings. It also debates the regulatory perspectives and challenges involved in PAT adoption, focusing on how stakeholders in the industry and agencies can integrate in developing and implementing innovations that will pass the test of compliance criteria. In general, what this paper presents is that PAT will drive pharmaceutical manufacturing into advancement for higher standards of quality with increased efficiency.