PAT: Exploring the New Philosophy of the FDA

The emergence of process analytical technology (PAT) and the guidance paper issued by the U.S. Food and Drug Administration (FDA) in 2003 show a clear shift in philosophy for pharmaceutical manufacturing. In this white paper, Automsoft details the FDA's move from the concept of "inspected quality" to a system of continuous quality management supported by key enabling technologies. Automsoft also discusses the importance of information technology in PAT, offers suggestions for manufacturers in implementing their own programs and considers barriers to implementation.

Implementation of a PAT program requires an information technology framework that can gather, filter and store large quantities of data and metadata, as well as a reporting system for analysis and modeling tools. Automsoft believes that technology for data acquisition and analysis will help manufacturers to optimize production and to implement PAT programs more quickly and effectively.

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