Regulatory Sciences Community

 View Only
Back to discussions
Expand all | Collapse all

Monitoring process Yield during PPQ/PV - FDA or EU guidance

  • 1.  Monitoring process Yield during PPQ/PV - FDA or EU guidance

    This message was posted by a user wishing to remain anonymous
    Posted 01-11-2024 12:23
    This message was posted by a user wishing to remain anonymous

    Hello, Appreciate input on this -- is  there  FDA or ICH guideline or position paper or presentation specifying that overall process yield need to be monitored as a part of IPCs or during PPQ/Process Validation?

    For biologics (monoclonal antibodies) or small molecules.

    thanks