Process Analytical Technology

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Process Analytical Technology or PAT has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters and quality attributes.

The FDA has outlined a regulatory framework<ref>FDA, Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004</ref> for PAT implementation. With this framework - according to Hinz<ref>Hinz, Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative; Anal Bioanal Chem, Vol 384, p1036-1042, 2006</ref> - the FDA tries to motivate the pharmaceutical industry to improve the production process. Cause of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.

Generally, the PAT initiative from FDA is only one topic within the broader initiative of "Pharamaceutical cGMPs for the 21st century - A risk based appraoch".<ref>FDA, Pharamaceutical cGMPs for the 21st century - A risk based appraoch; Final Report, September 2004</ref>

[edit] Long-term goals

The long term goals of PAT are to:

reduce production cycling time
prevent rejection of batches
enable real time release
increase automation
improve energy and material use
facilitate continous processing

Currently near-infrared (NIR) spectroscopy applications dominate the PAT projects. For a detailed review of PAT tools see Scott.<ref>Scott, Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement; PDA Journal of Pharmaceutical Science and Technology, Vol 60, No 1, p17-53, 2006</ref>