Dr. Ajoy Bera and Dr. Ashish Mukherjee
Central Drugs Laboratory, 3, Kyd Street, Kolkata –700 016
Received: 18 April 2014, Accepted: 15 June 2014, Published Online: 27 July 2014
Process Analytical Technologies (PAT) describes a system, which is for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality. The PAT initiative focuses on building quality into the product and manufacturing processes, as well as continuous process improvement. It is well known that pharmaceutical production involves the manufacture of the finished product, followed by laboratory analysis to verify quality. The disadvantages associated with this approach are continual process optimization, recurring manufacturing difficulties, and the possibility of failed batches. This article provides an overview of Process Analytical Technology and its application to the pharmaceutical industry. It, however, is a wide-ranging subject, which is expanding rapidly. Effective PAT implementation comprise of science-based understanding of the physical, chemical and mechanical properties of all elements of the proposed drug product. The overall PAT venture is promising for delivering an integrated systems approach for quality design, process analysis, understanding and control, continuous improvement, knowledge and risk-based management. The incorporation of early PAT devices, increase process efficiency and safety by acting on data in real time and by eliminating sampling. On the top of that PAT applications, increase detailed knowledge of processes, leading to increased robustness and greater processing opportunities. Emphasis is placed on chemometrics, which is the use of mathematical and statistical models to extract and interpret chemical data.
Keywords: Process Analytical Technology, ICHQ10, Process analyzers, cost control, chemometrics