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  • 1.  Accelerated stability data

    Posted 23-Jan-2019 05:52
    Hi,
     
    Would anybody have an idea whether you could market a device with 6 m accelerated stability data, the device has undergone changes with respect to packaging and coating.
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Associate

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    E  rpillay@ellex.com
    W ellex.com
    .............................................................................
     
    One Powerful Vision.
    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 
     

     
     
     


  • 2.  RE: Accelerated stability data

    Posted 24-Jan-2019 22:49
    ​Hi ,

    Just to add the device changes were only assessed as a 'Letter to File' for the FDA. For such changes which do not require a submission to FDA , can you please let me know whether along with 6 m accelerated , real time data is also required  before the device is marketed ? If real time is required then how many months  ? And do we require 3 lots on stability for these changes?

    ------------------------------
    RashmiAdelaideAustralia
    ------------------------------

    Original Message


  • 3.  RE: Accelerated stability data

    Posted 25-Jan-2019 03:45
    You may have to do the impact assessment of the change on the performance and shelf life of the device. Based on that you may want to revisit the shelf life and launch with a conservative shelf life upon 6 months data. Extend the shelf life later upon availability of real time stability data.

    ------------------------------
    Rashida Najmi, Sr VP
    Quality, Regulatory and Pharmacovigilance
    Piramal Enterprises Ltd
    Bethlehem PA
    USA
    ------------------------------

    Original Message


  • 4.  RE: Accelerated stability data

    Posted 25-Jan-2019 23:53

    If there are no performance issues during the 6m accelerated data , can the product be put on the market with 2 years shelf-life without real time data ?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


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