Regulatory Open Forum

 View Only

  • 1.  Modification of USP method and filing categories

    Posted 04-Aug-2020 11:38
    The quality lab at our site is adopting a USP method for Assay and ID by UV Spectrum (PDA detector).

    The method is being adopted as is, with exception of the Standard/Sample preparation for ID by UV.  The USP method has you take the assay standard and samples, and dilute them by 10-fold prior to injection for ID.  

    Our site verified the method using the regular Assay Standard/Sample (no dilution), as their is no scientific reason to dilute with the instrument capabilities at the site.  

    For filing purposes, does this become an "in-house method", as we have modified the USP method dilutions?  Does this affect the filing category from a CBE-0?

    We are just trying to understand the risk involved.  Any information would be great.  Thank you!

    ------------------------------
    Matthew Aksamit
    Regulatory CMC Author/Editor
    United States
    ------------------------------


  • 2.  RE: Modification of USP method and filing categories

    Posted 05-Aug-2020 12:34
    Edited by Deep Shah 05-Aug-2020 12:35
    Matthew:

    If your application was approved with USP method and now if you are proposing to change the method, this change will likely be CBE-30 (according to Section VIII.C.1.a - Guidance for Industry Changes to an Approved NDA or ANDA). Guidance states that any changes (except those qualified as PAS) in "regulatory analytical procedures" should be submitted as CBE-30. 

    However, you are allowed to introduce an "alternative" analytical procedure. If you can prove that the proposed change in sample prep doesn't reduce the assurance of identity, you can submit this through annual report (Section VIII.D.2 of the same guidance)

    Hope this helps! 

    Thanks,
    Deep

    ------------------------------
    Deep Shah, MS
    Global Regulatory Affairs CMC
    Seattle, WA
    ------------------------------

    Original Message


Related Content