iSixSigma

QbD

Viewing 5 posts - 1 through 5 (of 5 total)
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  • #25824

    Dhiman
    Participant

    hi,
    can any one tell me how QbD actually work in
    pharmaceutical manufacturing by giving some example.
    thanks,

    0
    #62548

    Jonathon Andell
    Participant

    I hear about organizations claiming to pursue it, but I haven’t seen examples. Overall, QbD is a process that wraps itself around new product development. One potential application is to ensure that the ultimate manufacturing process is able to perform defect-free and efficiently. I have seen a few of what I call “anti-examples,” in which lack of QbD led to really bad equipment design – I cannot reveal who or where, but they were doozies!

    0
    #62549

    Dhiman
    Participant

    thank you very much Jonathon Andell for your
    valuable time.based on my understanding of QbD- suppose we are
    talking about the manufacturing of tablet by wet
    granulation method, then one step is drying of the
    wet granule and by detail understanding of physical
    and chemical property of the material and
    performing the experiment we can decide about the
    design space for time and temperature of the drying.
    so every time we do for drying with that
    specification it will definitely gives quality
    product. is it considered as part of QbD??

    0
    #62551

    Jonathon Andell
    Participant

    This certainly sounds like a process that could benefit from QbD. The question now becomes one of how far along the project has progressed, and whether there remains time and opportunity to use the tools. If you would like to chat a bit, give me your email address and we can set up a time.

    0
    #62552

    Dhiman
    Participant

    hi,
    my email is [email protected]
    thanks,
    have a good day

    0
Viewing 5 posts - 1 through 5 (of 5 total)

The forum ‘Healthcare’ is closed to new topics and replies.