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  • 1.  separate specs for same product

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2018 10:50
    This message was posted by a user wishing to remain anonymous

    We have a client who is has a 1.3 mL dose (mAb) in a 3 mL vial. They need to also have a 1.8 mL fill volume for clinical reasons - same 3 mL vial, same stopper, same formulation, absolutely nothing changed but the fill volume. The CMO says they will need to do a whole new set of specifications.  I disagree.  Opinions?


  • 2.  RE: separate specs for same product

    Posted 01-Jun-2018 15:22
    I agree with CMO as 1.3 mL dose and 1.8 mL dose is considered to be a different strength, if its a unit dose injection. You need a separate specification for both individual strengths and need full study for each individual strengths.

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    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


  • 3.  RE: separate specs for same product

    Posted 02-Jun-2018 12:41
    I agree that it would be two different set of spec. Often fill volume is part of spec. As mentioned by Gaurav, as two fill volumes are for two different dose strength, it is probably better to have two spec sheets.

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    Partha Ghosh
    Germantown MD
    United States
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    Original Message


  • 4.  RE: separate specs for same product

    Posted 04-Jun-2018 12:35

    I would expect each configuration to have its own spec.  You can combine so both are in the same spec where you'd likely have same acceptance criteria for all tests except for fill volume.

    Tom

    Chicago

     




    Original Message


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