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  • 1.  Shipping Facility Change/Is shipping part of the "manufacturing activities"?

    This message was posted by a user wishing to remain anonymous
    Posted 14-May-2020 12:13
    This message was posted by a user wishing to remain anonymous

    Hi,

    Looking for advice/opinion please! 

    If there was a change to allow product (Class III sterile medical device) to be shipped from a warehouse would this change be deemed substantial/significant and require notification to BSI, TGA etc? Currently this warehouse is used only for storage of the finished product which is then transferred back to the main site for shipping. 

    Is shipping therefore considered part of the manufacturing activities?

    Thank you!


  • 2.  RE: Shipping Facility Change/Is shipping part of the "manufacturing activities"?

    Posted 15-May-2020 06:07
    Hello Anon,

    Off the top of my head, I would probably say no, but there is not necessarily enough information to make a complete determination.  In most cases, shipping is considered part of manufacturing activities and many regulatory agencies are looking at the entire life cycle of products.  The concept of "just manufacturing" needs to be thought of differently, because the entire life cycle of the product needs to be under control including shipping, transport, handling, storage, special conditions, etc.  Without more information, I would say shipping change may not be considered a significant change if there are no/minimal factors affecting the safety and performance of the device.  What you should do is conduct a little mini-risk assessment on the change of shipping from a warehouse to look at all criteria maybe impacting the safety and performance of the device, i.e. sterility, shelf life, packaging, transport, damage, etc.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Shipping Facility Change/Is shipping part of the "manufacturing activities"?

    This message was posted by a user wishing to remain anonymous
    Posted 15-May-2020 08:58
    This message was posted by a user wishing to remain anonymous

    Hi Richard,

    Thank you for getting back to me on this; much appreciated! I've been pondering over this for a while and I think I am of the same mind as you with regards to the impact on safety and performance, so it is really nice to have that reassurance! 

    I will definitely look into the risk assessment of the change.

    Thank you!
    Original Message


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