Process Analytical Technology ( PAT ) : A Real Time Quality Assurance

Process Analytical Technology (PAT) promise to deliver a bigger, brighter future in terms of encouraging “the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance” while ensuring patient safety and increasing profitability for the life sciences industry. No matter how you slice it, reducing raw material and batch losses, preventing scraps and rejects, insuring real-time release of product, increasing safety through the proliferation of automated manufacturing and facilitation of continuous process improvement through management of variability and improved efficiencies can lead to better product quality, enhanced consumer safety and increased profitability. It promises to be the most radical change in pharmaceutical manufacturing in 30 years. It’s actually a part of the US Government FDAs’ 21 century initiative, built into its strategic plan & supported by Presidential Executive order 13329encouraging innovation in manufacturing. The scope of this article is to introduce the reader to PAT. It, however, is a wide-ranging subject, which is expanding rapidly.