Enhanced Approaches to the Identification, Evaluation, and Control of Impurities
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A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced or quality by design (QbD) development for the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supply chain and control strategy, and how changes to such outcomes are managed over the lifecycle. A series of articles will address “flexibility” and look to provide recommendations for the further development of the ICH Q11 vision. The focus of this work will address flexibility associated with the “Enhanced Approaches to the Identification, Evaluation and Control of Impurities.”
KeywordsICH Q11 Chemistry Control strategy Quality by design QbD Process Methods Models CMC Regulatory flexibility PAT ATP
The authors acknowledge the following for their input and support: Dave White, Kevin Seibert, Tim Watson, Steve Tymonko, Lindsay Hobson, Sushil Srivastava, Tim Curran, Asher Lower, John R Donaubauer, Nathan Ide, and John Lepore.
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