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  • 1.  CBE-30 question

    Posted 25-Jan-2017 09:26
    Hello Everyone,
    Can multiple changes be submitted in a CBE-30?

    Thank you,

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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  • 2.  RE: CBE-30 question

    Posted 26-Jan-2017 09:28
    So, if all the changes are related to one overall master (or parent) change and they all fall into the CBE-30 category or less (CBE-0, annual report), then yes it is appropriate for all the changes to be submitted in one CBE-30.

    For example, a manufacturing site change for an immediate release product and all the associated changes that go along with site transfer, such as: equipment changes, process parameter adjustments, batch size adjustments, etc...

    Also, the June 2014 FDA "Changes" guidance talks about including a list of all changes in the supplement in the "General Requirements" section. So from that you can infer the multiple changes can be submitted in one supplement.

    If the changes are unrelated, for example different changes at different manufacturing sites or a labeling change and a spec change. Then you should do separate supplements, so that the deficiencies in one change does not hold up approval for the other change.

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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    Original Message


  • 3.  RE: CBE-30 question

    Posted 26-Jan-2017 11:00

    Hi, Sarah –

     

    I am not aware of any regulation/guidance that would  prevent this approach. However, I have never included multiple changes unless they were all related to the same larger change – otherwise, there is a risk that concerns or questions about one change could put all the changes in jeopardy. And, if you have inadvertently included a change that should have been submitted as a PAS, you may have other issues.

     

    Is there a reason to include the multiple changes together?  Always interested to learn!

     

    Cathy

     

    ​​​​​

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC




    Original Message


  • 4.  RE: CBE-30 question

    Posted 26-Jan-2017 11:24

    Yes.  As long as they all fall in the CBE-30 category.  I've done this several times and am actually working on one now (new test sites and revised analytical method)

    Tom

    Chicago




    Original Message


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