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  • 1.  Bracketing with different expiration dates

    Posted 18-Sep-2017 12:47
    ​​Hi,
    Can you bracket the middle fill in a stability program, if the different fill sizes have different expiration dates? For example:

    100 mL Fill, exp 18 months
    250 mL Fill, exp 18 months
    1000 mL Fill, exp 24 months

    (These are terminally sterilized NDA products.)

    Cindy

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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  • 2.  RE: Bracketing with different expiration dates

    Posted 18-Sep-2017 17:01
    ​Cindy, been a while since I last worked in pharma but if I remember right, bracketing should be acceptable in your case provided the concentration remains constant across the range (i.e. x mg/mL across all fills).

    Regards

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    Homi Dalal RAC
    Regulatory Affairs Leader
    Dynamic Controls
    Christchurch
    New Zealand
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    Original Message


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