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 (CPP) which affect the critical quality attributes (CQA).

The concept aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner (preferably in-line or on-line) and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects.

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 approach".[3]

  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, Pharmaceutical cGMPs for the 21st century – A risk based approach; Final Report, September 2004