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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 for PAT implementation. With this framework - according to Hinz - 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".
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)
The long term goals of PAT are to:
Currently near-infrared (NIR) spectroscopy applications dominate the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD) . For a detailed review of PAT tools see Scott , or Roggo .
|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.|