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Switching from Terminal Sterilization to Aseptic Processing in an ANDA

  • 1.  Switching from Terminal Sterilization to Aseptic Processing in an ANDA

    Posted 22-Oct-2022 12:57
    Hi,
    I am working on a generic product where the RLD was approved many years ago using terminal sterilization.  R&D has discovered the heat from TS increases the potential for nitrosamine and another impurity formation.  Has anyone proposed aseptic processing in an ANDA using the data gathered on a batch tested pre and post TS to show the impact as justification?  Does it need a controlled correspondence or will it be ok to just include the data and proceed with the aseptic processing for the exhibit batches?

    Thanks,
       Lisa

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    Lisa Apolis, RAC
    Apolis Regulatory Consulting
    Georgia, USA
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