Quality-by-Design and PAT: 21st Century-Approach to Quality

As part of the FDA’s cGMPs for the 21st Century and Critical Path Initiative” both the pharmaceutical and CMC regulatory programs were reviewed and evaluated by FDA in an effort to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. From this evaluation the concepts of Quality-by-Design and Process Analytical Technology were developed by FDA and introduced to industry as an acceptable approach to the design of manufacturing processes and quality systems. The concepts offer regulatory flexibility and present challenges.