Regulatory Open Forum

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  • 1.  Request for info

    Posted 13-Feb-2018 15:17
    Can anyone let me know if there are any guidelines for proposing a shelf life for a combi pack ( One secondary pack containing Drug Product and diluent) if the stability data supporting shelf life is more for Drug product when compared with Diluent.

    Regards,
    Indraneel D

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    Indraneel Dasari RAC
    Associate Director
    HYDERABAD
    India
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  • 2.  RE: Request for info

    Posted 14-Feb-2018 09:17

    For a combi pack that contains two products, you will only be able to use the shortest expiry.  If your diluent expires after 12 months, and your drug product expires after 24, the labeled expiry on the pack will be 12 months.

     

    This also comes up in situations when the expiry for device components for a combination product (such as a pre-filled pen) expire before the drug product.  For patient safety, the combination product expiry cannot exceed the shortest expiry of any of the components.

     

    Best regards,

     

    Cathy

     

     

     

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC

     




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