Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

Minimum stability batch requirements

  • 1.  Minimum stability batch requirements

    This message was posted by a user wishing to remain anonymous
    Posted 15-Mar-2018 09:24
    This message was posted by a user wishing to remain anonymous

    Requirements to file a NDA/ANDA – A client would to prepare 3x 50L batches.

    I was told that FDA no longer accepts less than 100L in order to scale up 10 times.

     

    Is there an FDA reference that dictates a minimum 100L batch size?



Related Content