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  • 1.  Europe_Component Sterilization Info

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2019 09:58
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    Greetings..!!!

     I'm compiling a dossier (Lyo product) for Europe market (DCP). I would like to know, if it is required to include components sterilization information (i.e., Tunnel and autoclave qualification  information) in the dossier. Can anyone please let me know the requirement.

    Thanks in advance.



  • 2.  RE: Europe_Component Sterilization Info

    Posted 17-Jan-2019 15:10
    Generally it is not required to provide that level of information in Europe. They assume that is covered by the GMP inspection.​

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


  • 3.  RE: Europe_Component Sterilization Info

    Posted 18-Jan-2019 03:26
    Edited by Balachandu Mullapudi 18-Jan-2019 03:27
    Thank you for the info.
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    Original Message


  • 4.  RE: Europe_Component Sterilization Info

    Posted 20-Jan-2019 04:02
    Hi
    there is no EU recommendation regarding such components, but I recommend to add this sterilisation information.

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    Evangelos Tavandzis
    Praha
    Czech Republic
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    Original Message


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