Process Analytical Technology
Process Analytical Technology (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 [FDA, Guidance for industry: PAT — A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004] for PAT implementation. With this framework — according to Hinz [Hinz, Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative; Anal Bioanal Chem, Vol 384, p1036-1042, 2006] — the FDA tries to motivate the pharmaceutical industry to improve the production process. Because 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 "Pharmaceutical cGMPs for the 21st century — A risk based approach". [FDA, Pharamaceutical cGMPs for the 21st century — A risk based approach; Final Report, September 2004]
The challenge to date with PAT for pharmaceutical manufacturers is knowing how to start. A common problem is picking a complex process and getting mired in the challenge of collecting and analyzing the data.
The following criteria serve as a basic framework for successful PAT roll-outs: (From [http://www.pattoolkit.com/PATPrimer.htm A PAT Primer] )
* Picking a simple process. (Think Water for Injection (WFI) or Building Monitoring System (BMS)
* All details and nuances are well understood and explained for that process.
* Determine what information is easily collected and accessible through current instrumentation.
* Understanding the appropriate intervals for collecting that data.
* Evaluating the tools available for reading and synchronizing the data.
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 continuous processing
Currently near-infrared (NIR) spectroscopy applications dominate the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD) [Williams, J: "Healthcare Distributor", page 81. E.L.F. Publications, Inc., December 2006/January 2007] . For a detailed review of PAT tools see Scott [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] , or Roggo [Roggo, A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies Journal of Pharmaceutical and Biomedical Analysis, Volume 44, Issue 3, 27 July 2007, Pages 683-700] .
* [http://www.fda.gov/cder/OPS/PAT.htm FDA: PAT Initiative]
* [http://www.emea.europa.eu/Inspections/PAThome.html EMEA: Inspections - Process Analytical Technology]
* [http://www.astm.org/cgi-bin/SoftCart.exe/COMMIT/COMMITTEE/E55.htm?L+mystore+vrqp2862 ASTM PAT Committee]
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