Process Analytical Technique (PAT): An Integral Part of Pharmaceutical Process Automation
Keywords:
Process Analytical Technique, Chemometric, Quality by Design, US FDAAbstract
Process Analytical Technology (PAT) is a system for designing, analyzing and controlling manufacturing process through timely measurements of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry in manufacturing area. PAT involves the use of different technologies and tools to build quality into the products. Different techniques are described for typical steps in the production of drug substance and drug product. These methods are mainly based on spectroscopy and other optical sensors, in combination with chemometric multivariate data evaluation tools. Pharmaceutical companies face many challenges while implementing PAT into their new and pre-existing manufacturing processes. To make the Pharmaceutical process Automation effective the implementation of Process Analytical Technique (PAT) in the Process is very important to avoid human interference. So this review includes discussion about the PAT in details which is very important.
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