The FDA Process Analytical Technology (PAT) initiative is an effort to facilitate the introduction of new technologies into manufacturing in the pharmaceutical industry. Today's competitive industrial environment requires drug manufacturing that continuously strives to improve product quality while reducing production costs. The goal of PAT is to enhance understanding and control this manufacturing process, which is consistent with the FDA's current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
In routine manufacturing, PAT enables continuous and real-time quality assurance to ensure consistently high product quality and performance, batch after batch. Structured product and process development, using experimental design and on or in-line process analysers to collect data in real time, can provide increased insight and understanding for process development, optimisation, scale-up, technology transfer, and control. Process understanding then continues in the production phase when other variables (e.g., environmental and supplier changes) may possibly be encountered. Therefore, continuous learning over the life cycle of a product and applying those learnings is important.
