Sonali Mahaparale and Pallavi Gaikwad*


Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both off-line, on-line & in-line.The main principle of PAT is the use of different technologies and tools to build quality into the products. Effective implementation of PAT comprise of science-based understanding of the physical, chemical and mechanical properties of all elements of the proposed drug product. The application of early PAT devices, increase safety & process efficiency by acting on data in real time and by eliminating sampling. PAT applies it gives brief knowledge of processes, leading to increased robustness and greater processing opportunities. chemical reactions and process monitoring such as drying, distillations, crystallizations, hydrogenations, and others provided by Modern developments in analytical technologies. while implementing PAT into their new and pre-existing manufacturing processes many pharmaceutical companies face many challenges and problems. In this paper, we will start with brief PAT concepts, Introduction, How PAT works, Importance of PAT tools, PAT implementation steps and a review of their application in the wider pharmaceutical industry.

Keywords: PAT, Hyphenated techniques, Critical Process parameters (CPP), ICHQ10.

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