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  • 1.  Usage of API during FP manufacturing

    Posted 08-Aug-2022 05:27
    Hii Team,

    Is it mandatory that expiry of the Finsihed Product shelf life should not exceed expiry of API
    Or we can use valid API during(near to expire or valid with less expiry)finished product batch manufacturing?
    please share any guidance if available.


    Thanks & Regards,
    Himanshu Parate

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    Himanshu Parate
    Kalyan
    India
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  • 2.  RE: Usage of API during FP manufacturing

    This message was posted by a user wishing to remain anonymous
    Posted 08-Aug-2022 10:38
    This message was posted by a user wishing to remain anonymous

    As long as the API is used within its valid expiry date, you are fine but your FP or DP expiry data starts from the date of manufacturing of the FP or DP (when you add API to the FP/DP ingredients, the expiry of API no longer matters in determining the Expiry of FP/DP).
    Original Message


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