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  • 1.  GLP Toxicology Study

    This message was posted by a user wishing to remain anonymous
    Posted 30-Nov-2018 16:18
    This message was posted by a user wishing to remain anonymous

    Can you initiate a GLP toxicology study in Europe/US without a Certificate of Analysis (CoA) for the test article?

    Identity, Composition, Strength, Purity, Stability, and Safety Data Sheets of the test article are provided during study initiation. The CoA will be provided during the course of the GLP study. Is that acceptable?

    Thanks.


  • 2.  RE: GLP Toxicology Study

    Posted 12-Dec-2018 12:23
    The answer to this question depends on the laboratory that you are using, and their procedures.  In general, there is no regulatory requirement that requires a COA if you have the other information provided.

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    Jackie Torfin
    Vice President, Global QA and Regulatory Compliance
    Maple Grove MN
    United States
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    Original Message


  • 3.  RE: GLP Toxicology Study

    Posted 22-Dec-2018 16:09
    Yes that should be fine and you can go ahead with a risk based approach. If however later you end up with any non compliance in the CofA you will have to perform the impact assessment and that could lead the GLP study thus far done to be voided.

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    Rashida Najmi, Sr VP
    Quality, Regulatory and Pharmacovigilance
    Piramal Enterprises Ltd
    Bethlehem PA
    USA
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    Original Message


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