Process Analytical Technology (PAT): What Is It All About?,

Process analytical technology (PAT) combines several measurement, data analysis, and process control techniques that, when applied appropriately, can result in more-efficient manufacturing of high-quality product. PAT has been widely practiced in the chemical process industries (CPI) for decades, especially in the control of chemical processes. However, despite documented successes, PAT implementation in the pharmaceutical and biotech industries has evolved more slowly than in other segments of the CPI. The FDA and industry have developed a new paradigm for use by drug developers and manufacturers known as Quality by Design (QbD) and Risk Management, of which PAT is a key component. In this initiative, use of state-of-the-art process analytics in pharmaceutical and biotech manufacturing is being encouraged for implementation in a way that maintains minimal risk to product quality. This article explains what PAT is and presents a few examples of its implementation in pharmaceutical and biotech manufacturing.