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  • 1.  Batch Numbering System (Finished Biological Product)

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jan-2019 17:13
    This message was posted by a user wishing to remain anonymous

    Hi Folks 
    I have a question:

    1- Should the batch numbering system for the finished product be described in module 3?
    2- If yes, which section?


  • 2.  RE: Batch Numbering System (Finished Biological Product)

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2019 10:14
    This message was posted by a user wishing to remain anonymous

    Please keep this sort of information on site for PAI.
    Original Message


  • 3.  RE: Batch Numbering System (Finished Biological Product)

    Posted 17-Jan-2019 15:15
    ICH M4Q doesn't specify it for the drug product (or finished goods), as it does for drug substance, but if there's anything possibly confusing about it, I would include it in 3.2.P.3.3.​

    ------------------------------
    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


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