Process analytical technology

Process analytical technology (PAT) has been defined by the United States <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a> (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of <a href="/facts/Critical_process_parameters/Y3N73X2B">critical process parameters</a> (CPP) which affect the <a href="/facts/Critical_to_quality/KjJcUA2z">critical quality attributes</a> (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 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 approach".

Process analytical technology open-in-new

Process analytical technology