Process analytical technology--It's not rocket science, but it is science, math, control, and IT

摘要

The pharmaceutical manufacturing industry has had to work within the constraints of regulation for many decades, which has inhibited a culture of continuous process improvement and caused less than optimal manufacturing practices. There is a reluctance to change a validated process that may require regulatory approval. The Food and Drug Administration's (FDA's) initiative for current good manufacturing practices (CGMPs) for the twenty-first century has encouraged the adaption of new technologies to improve manufacturing. Process analytical technology (PAT) is one of these technologies. This article presents some of the challenges and best practices related to implementing PAT and gives a perspective on lessons learned.