(661g) Case Study: QbD Approach to Design Space Verification
AIChE Annual Meeting
2016
2016 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Quality By Design in Drug Substance Process Development
Thursday, November 17, 2016 - 10:36am to 10:57am
Design Space Verification was completed for a recent regulatory filing using the Quality by Design paradigm for a drug substance process. A risk analysis approach was utilized to identify the key issues to address in order to verify that the design spaces derived from laboratory scale experiments were appropriate for commercial scale production.