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  • 1.  GMPs for Key Reagents

    Posted 01-Mar-2022 10:37
    Are there GMP guidelines specific to key reagents (in this case an enzyme) used in the production of biologics?  The reagent does not incorporate into the final drug substance and is removed during down stream processing.

    Are full API GMPs requires or is there a subset of GMPs that apply?

    Thanks



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    Ken Rose
    Painesville OH
    United States
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  • 2.  RE: GMPs for Key Reagents

    Posted 02-Mar-2022 02:54
    Hi Ken: You mention 'key reagent', enzyme. I am assuming, being an enzyme, it would be considered a critical reagent and would, therefore, require to be manufactured per cGMPs to ensure performance consistency, quality and so on. Hope this helps. 
    Kind Regards, Hazel

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    Hazel Aranha PhD, RAC
    Consultant
    East Northport NY
    United States
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    Original Message


  • 3.  RE: GMPs for Key Reagents

    This message was posted by a user wishing to remain anonymous
    Posted 02-Mar-2022 10:02
    This message was posted by a user wishing to remain anonymous

    Full GMPs apply for any drug/biologics API intended for humans! Reagents should comply with compendial monographs! If they are functional reagents, you should either comply with compendial monographs or if they are proprietary, should comply with GMPs plus have all the composition, CMC information ready to be submitted in the NDA/BLA. You could also have a DMF.
    Original Message


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