Case for Process Analytical Technology Regulatory and Industrial Perspectives

CASE FOR PROCESS ANALYTICAL TECHNOLOGY REGULATORY AND INDUSTRIAL PERSPECTIVES 

Duquesne University, Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania 

Pharmaceutical Manufacturing Handbook Regulations and Quality, edited by Shayne Cox Gad Copyright 2008 John Wiley Sons, Inc. 

Process analytical chemistry generally describes the science and technology associated with displacement of laboratory-based measurements with sensors and instrumentation positioned closer to the site of operation. Although industrial process analyzers have been in use for more than 60 years [3], the modern period of essentially began with the formation of the Center for Process Analytical Chemistry (CPAC) in 1984 [4]. As described by Callis, Illman, and Kowalski [5], the goal of 

The industrial movement has been bolstered by two decades of advances in materials science, electronics, and chemometrics. Since the inception of CPAC, the pace of innovation in sensors, instrumentation, and analytics has quickened dramatically. The development of more robust, sensitive photodetector materials, microelectromechanical systems (MEMSs), and fiber optics and the perpetual advancement of computing power (as predicted by Moore s law) have both increased the performance and reduced the cost of . As a result, is now a critical part of routine operations within the realm of industrial chemistry. Many general reviews on the subject of (and PAT) have been published [6—10]. A series of literature reviews on the subject of have been published regularly in Analytical Chemistry. 

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Robert P. Cogdill, Duquense University Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania, Case for Process Analytical Technology Regulatory and Industrial Perspectives... 

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