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Abstract

PROCESS ANALYTICAL TECHNIQUE

Kamble Santosh. M*, Gholve S.B, Sayyed Sarfaraz Ali, Ganesh Surkute, Tanaji Nirmal, Amol Duve

Abstract

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on an understanding of the scientific and engineering principals involved, and identification of the variables which affect product quality. The PAT initiative is based on the FDA (The US Food and Drug Administration) belief that: ―quality cannot be tested into products; it should be built-in or should be by design.‖ Process Analytical Technologies (PAT) are used to provide and inform timely analysis of critical quality parameters with the end goal of improving final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry in manufacturing area. The potential for improved operational control and compliance resulting from continuous realtime quality assurance was highlighted as a likely benefit that would result from PAT implementation. In this paper, we will start with brief PAT concepts, Introduction, Historical view, Regulatory view, PAT tools, Pat implementation and a review of their application in the wider pharmaceutical industry. The first steps in an Analytical Quality-by-Design (AQbD) method development include understanding the analysis needs (e.g., purpose, specificity, sensitivity, cycle time, on-line/off-line, qualitative/quantitative, accuracy, precision) and selection of the technique that will meet these criteria. One set of analytical tools applied during the development and scale-up of drug substances and dosage forms include in-situ analytics, chemometrics and modelling i.e., Process Analytical Technology (PAT) tools. Pharmaceutical companies face many challenges and problems while implementing PAT into their new and pre- existing manufacturing processes. This article discusses the challenges and problem encountered. The scope of this article is to introduce the reader to PAT. It, however, is a wide – ranging subject, which is expanding rapidly

Keywords: Process analytical technology, Quality by design, critical quality attribute.


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