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Quality by design

  • At: 2007 FIP Congress in Beijing (China)
  • Type: Presentation
  • By: BUHSE, Lucinda (FDA, St. Louis, United States of America)
  • Abstract:

    The US FDA’s new science and risk-based pharmaceutical quality assessment system (PQAS) is based on principles of Quality by Design (QbD) that will promote a more scientific approach to quality assurance through product and process understanding. A thorough understanding of which process parameters and raw material characteristics affect

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Last update 4 October 2019

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