Process analytical technology – A review of game changer regulatory framework by US FDA

Abstract

The concept of process analytical technology is introduced with the purpose of providing important information after the analysis of critical quality parameters which can have direct or indirect impact on the product quality. This type of information is helpful in maintaining the product quality while keeping the manufacturing cost low. The implementation of PAT will potentially improve the operational control and compliance as per regulatory guidelines for continuous real time quality assurance during manufacturing. The concept is relatively new for both academia and industry hence Considerable amount of study has been carried out to explore the various aspects of PAT guidelines and their successful implementation. This review mainly contains introduction and background of PAT guidelines as the first step in QBD implementation. Detailed understanding of analysis and selection of suitable analytical technique is the most important aspect of PAT guidelines. These analytical techniques will even play crucial role at the time of scale up and detailed evaluation of drug and dosage forms. The main purpose of this review is to understand the right perspective of PAT guidelines towards the goal of achieving products with highest quality.