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

Venue: Online

Location: -, United States

Event Date/Time: Oct 03, 2007 End Date/Time: Oct 03, 2007
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FDA, Pharma, CMO, and the Regulatory Consulting Industry Perspectives on Implementing Quality Concepts

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.