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[1] for PAT implementation. With this framework - according to Hinz[2] - 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".[3]
[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.[4]
[edit] Footnotes
- ^ FDA, Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004
- ^ Hinz, Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative; Anal Bioanal Chem, Vol 384, p1036-1042, 2006
- ^ FDA, Pharamaceutical cGMPs for the 21st century - A risk based appraoch; Final Report, September 2004
- ^ 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
