Regulatory Open Forum

 View Only

  • 1.  Stability data for registration in EMA

    This message was posted by a user wishing to remain anonymous
    Posted 18-May-2021 08:44
    This message was posted by a user wishing to remain anonymous

    Dear community,

    Ask you to help with stability data for registration in EMA. We need to registrate biological drug product for intravenous ingection (like human immunoglobulin).
    Could we study stability  for drug product by 1 strenth(concenrtation) based on data just for 1 batch ?
    Or could we study stability  for drug product by 1 strenth(concenrtation) based on data for 3 batch but different sizes of conteiner?

    Best regards.


  • 2.  RE: Stability data for registration in EMA

    This message was posted by a user wishing to remain anonymous
    Posted 19-May-2021 11:19
    This message was posted by a user wishing to remain anonymous

    Dear community,

    Ask you to help with stability data for registration in EMA. We need to registrate biological drug product for intravenous ingection (like human immunoglobulin).
    Could we study stability  for drug product by 1 strenth(concenrtation) based on data just for 1 batch ?
    Or could we study stability  for drug product by 1 strenth(concenrtation) based on data for 3 batch but different sizes of conteiner?

    Best regards.
    Original Message


Related Content