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  • 1.  Periodic or skip testing

    This message was posted by a user wishing to remain anonymous
    Posted 30-May-2018 08:59
    This message was posted by a user wishing to remain anonymous

    Dear All 

    Would you please confirm the submission classification for the change from the batch-to-batch analysis to a pre-selected batches
    and / or at predetermined intervals assuming that historical data evaluated and no concerns. 


  • 2.  RE: Periodic or skip testing

    Posted 31-May-2018 11:59
    It will be only determined based on additional details: Drug substance or Drug Product, dosage form type, stability data, testing method, etc...

    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
    ------------------------------

    Original Message


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