Process Analytical Technology

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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]

Contents

[edit] 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.

[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 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].

[edit] Footnotes

  1. ^ FDA, Guidance for industry: PAT — A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004
  2. ^ Hinz, Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative; Anal Bioanal Chem, Vol 384, p1036-1042, 2006
  3. ^ FDA, Pharamaceutical cGMPs for the 21st century — A risk based approach; Final Report, September 2004
  4. ^ Williams, J: "Healthcare Distributor", page 81. E.L.F. Publications, Inc., December 2006/January 2007
  5. ^ 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
  6. ^ 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

[edit] References