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Enhanced Approaches to the Identification, Evaluation, and Control of Impurities

  • Matt E. PopkinEmail author
  • Phil J. Borman
  • Batool Ahmed Omer
  • Adam Looker
  • Jeffrey M. Kallemeyn
Perspective
  • 293 Downloads

Abstract

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.”

Keywords

ICH Q11 Chemistry Control strategy Quality by design QbD Process Methods Models CMC Regulatory flexibility PAT ATP 

Notes

Acknowledgements

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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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018
corrected publication 2019

Authors and Affiliations

  • Matt E. Popkin
    • 1
    Email author
  • Phil J. Borman
    • 1
  • Batool Ahmed Omer
    • 1
  • Adam Looker
    • 2
  • Jeffrey M. Kallemeyn
    • 3
  1. 1.Product Development and SupplyGlaxoSmithKline LtdStevenageUK
  2. 2.Process ChemistryVertex Pharmaceuticals Inc.BostonUSA
  3. 3.AbbVie Inc.North ChicagoUSA

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