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[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]
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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
The challenge to date with PAT for pharmaceutical manufacturers is knowing where to start and the trick to having this success and breaking the inertia of starting PAT is to begin with the right process.
The following criteria serve as a basic framework for how to get started: 1. Pick Simple. (Think Water for Injection (WFI) or Building Monitoring System (BMS) 2. All details and nuances are well understood and explained for that process. 3. Determine what information is easily collected and accessible through current instrumentation. 4. Understanding the appropriate intervals for collecting that data. 5. Evaluating the tools available for reading and synchronizing the data.
Currently near-infrared (NIR) spectroscopy applications dominate the PAT projects. For a detailed review of PAT tools see Scott [4], or Roggo [5].
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 approach; 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
- ↑ 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
References
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