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  • 1.  Pharmacopoeia Reference

    Posted 23-Nov-2018 05:07
    Dear Members,

    We have developed & validated a method of a Product as per Current USP monograph which is USP-41. However, as per recent USP Pharmacopoeial forum, this method(Specifically Impurity Method) is going to be revised in the USP 43(4) & accordingly we have validated the impurity method again as per the draft USP method.

    Therefore, can we claim the impurity method as per USP or we have to claim it as an In-house since it doesn't reflect the current USP monograph.

    Thanks in advance for your valuable comments.

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    Thanks & Best regards

    Rajib Kumar Baishnab
    Manager, Regulatory Affairs
    The ACME Laboratories Ltd.
    Dhamrai, Dhaka-1350, Bangladesh
    Ph: +8801990-407587
    Email: rbaishnab.qo@acmeglobal.com
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  • 2.  RE: Pharmacopoeia Reference

    Posted 23-Nov-2018 09:01
    The FDA compliance POLICY:
    "Articles shipped prior to and after the official date of the current USP or NF:

                   A. All official articles shipped after the current USP/NF became official should be in compliance with the
                  current compendia.

                   B. All official articles shipped prior to the date that the current USP/NF became official should be in
                  compliance with the official compendia in effect at the time of shipment."


    Hope the above helps!

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    GRSAOnline
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    Original Message


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