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  • 1.  Chinese Pharmacopeia

    Posted 30-Jun-2022 11:30
    Hi Everyone,
    In an IND application for US submission, under the CMC section, if Chinese pharmacopeia is used for the microbial limit test; what other supporting information can be added to provide justification and acceptance.

    Thanks

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    Pallavi Sharma
    Florham Park NJ
    United States
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  • 2.  RE: Chinese Pharmacopeia

    Posted 01-Jul-2022 01:05
      |   view attached
    Dear Please find attached highlited portion of FDA guidance. and attached guidance 2021.


    ------------------------------
    [SANKET] [SHAH] [ REGIONAL MANAGER]
    [QA AUDITOR]
    [ABBOTT]
    [MUMBAI] [MAHARASHTRA]
    [INDIA]
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    Original Message


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