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  • 1.  NDA Mod 3: primary (registration) stability batches

    This message was posted by a user wishing to remain anonymous
    Posted 06-Apr-2023 08:30
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,
    Does anyone have experience wherein none of the Primary stability batches were used in the clinic - i.e. for phase 2 or phase 3 clinical trial material?
      -- additionally, the clinical trial batch (site 1) was manufactured at a different site than the  primary stability batches (site 2). 

    Appreciate your thoughts on how to justify the lack of any clinical experience with primary stability batches and what comparative data would be sufficient?
    It is for oral dosage form, BCS 1.

    I ask because FDA/regulators more recently are interested for clinically relevant specs (release and expiry/shelf-life).
    Thanks




  • 2.  RE: NDA Mod 3: primary (registration) stability batches

    Posted 10-Apr-2023 14:51

    I have experience where none of the primary registration stability batches were used in the clinic.  Since you have two sites, a technical transfer report should be written to justify any differences in the manufacturing processes or testing and summarized in the NDA development section 3.2.P.2.  Showing that the clinical and primary batches are equivalent is the justification you need.  You will need to submit the release and stability data for all 4 (more?) batches, as well.



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    Janet DeLeon
    CEO
    DeLeon Pharmaceutical Consulting, LLC
    janet@deleonpharma.com
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    Original Message


  • 3.  RE: NDA Mod 3: primary (registration) stability batches

    Posted 11-Apr-2023 09:13

    I have experience where not of the primary stability batches were used in the clinic. I do not think that this is unusual  for the FDA, as typically you are have already started your registration trials before you do the DOE work, etc. for you commercial/primary stability batches. These are the batches which reflect your commercial process and from which you will assign an expiry date. However, this is separate from bioequivalence issues, which you are also touching on.

    Regards,
    Rob



    ------------------------------
    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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    Original Message


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