Abstract

REVIEW ON PROCESS ANALYTICAL TECHNIQUES AND IT’S TOOLS AND APPLICATION IN PHARMACEUTICAL INDUSTRY

Alka N. Chaudhary* and Kiran Singh

ABSTRACT

PAT is a system for designing, analyzing and controlling manufacturing processes by timely measurement of critical process parameters that affecting critical quality attributes. PAT monitors the quality of raw material properties both physically and chemically (i.e. at off-line, on-line, in-line). PAT requires a change from building quality testing to product quality testing in a variety of intermediate steps. It saves a large amount of time and resources required for sampling and review of products. The main objective of PAT is to provide effective tools such as multivariate data analysis and acquisition tools, modern process analyzers or analytical chemistry, controlling tools, endpoint process monitoring, and continuous improvement and knowledge improvement tools. Through this review, an attempt has been made to discuss the concept of PAT, benefits, different tools and applications.

Keywords: Process Analytical Techniques, ICH, USFDA, QBD.