White Paper Abstract

While 21 CFR Part 11 deals primarily with technology and its application, PAT has much farther-reaching objectives. Specifically, the FDA is attempting to transform the way drugs are made today and in the future. This represents a major cultural change for drug manufacturers with benefits that far outweigh the challenges that can come with applying new technologies. And, with major regulatory and financial drivers as incentive, PAT presents the opportunity to revolutionize the way drugs are made.