Using ASAPprime® Modeling for QbD

ASAPprime® and QbD


Quality by Design (QbD) for stability requires understanding factors that influence stability


Temperature and relative humidity impact

Packaging impact

Lot-to-lot consistency

  • Active lots
  • Excipient (ingredient) variability
  • Process variability

Can use ASAPprime® with Designs of Experiment (DOE) to examine range of factors

  • Data fitting allows easier statistics on for factor impacts
  • Enables setting specifications and finding interaction terms for stability

May not be able to scope all variables

  • Quality by Testing (QbT) using ASAPprime® may de-risk future changes
  • Run ASAP on product after changes to test impact


Read more about the use of ASAPprime® in QbD 


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