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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 (CPP) which affect Critical Quality Attributes (CQA). The concept actually 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〔FDA, Guidance for industry: PAT – A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004〕 for PAT implementation. With this framework – according to Hinz〔Hinz, Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative; Anal Bioanal Chem, Vol 384, p1036-1042, 2006〕 – 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".〔FDA, Pharmaceutical cGMPs for the 21st century – A risk based approach; Final Report, September 2004〕 ==The basics== PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach. It involves defining the Critical Process Parameters (CPPs) of the equipment used to make the product, which affect the Critical Quality Attributes (CQAs) of the product and then controlling these CPPs within defined limits. This allows manufacturers to produce products with consistent quality and also helps to reduce waste & overall costs. This mechanism for producing consistent product quality & reducing waste presents a good case for utilising continuous manufacturing technologies. The control of a steady state process when you understand the upstream & downstream effects is an easier task as common cause variability is easier to define and monitor. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Process analytical technology」の詳細全文を読む スポンサード リンク
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