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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.

Additional recommended knowledge

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. 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 appraoch".[3]

PAT implementation

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 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.

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 continuous processing

Currently near-infrared (NIR) spectroscopy applications dominate the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD) [4]. For a detailed review of PAT tools see Scott [5], or Roggo [6].

References

  • FDA: PAT Initiative
  • EMEA: Inspections - Process Analytical Technology
  • ASTM PAT Committee
 
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Process_Analytical_Technology". A list of authors is available in Wikipedia.
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