Good Clinical Practice Guide
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Thread: Monitoring of temperature during transportation from depot to site.

  1. #1
    Forum Member
    Join Date
    Nov 2011

    Monitoring of temperature during transportation from depot to site.

    Dear All,

    Please can someone let me know who is responsible for temeprature monitoring for IMPs during transportation from depot/manufacturer to site.
    Is it QP's responsibility or receiving site personel responsibility or sponsor's responsibility?
    If we are sponsor and we outsource manufacturing of IMP to xyz company, do we need to make sure that shipment should accompany thermometer? or it is responsibility of manufacturing site, if the IMP is storage is room temperature.
    If manufacturer says you dont need transition temperature monitoring then do we need to ask for data or stability testing report.

    I was in a assumption that manufacturing site QP is responsible for temperature monitoring of IMP during transportation of shipment.
    Please kindly comment on this issue.

    Many thanks in advance

  2. #2
    EU Guidelines to Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use (Annex 13) July 2010 states 'Shipping of investigational products should be conducted according to instructions given by or on behalf of the sponsor in the shipping order.' therefore it will depend on what you have agreed in the technical agreement with the IMP manufacturer.

    It is ultimately the responsibility of the sponsor to determine what is required but you should consider the advice from the QP/manufacturer.

    Note - the MHRA Moderator has provided a response in this instance as a number of weeks have passed without a response from other users

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