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  • 1.  Mixed lots within shipper which is saleable unit

    This message was posted by a user wishing to remain anonymous
    Posted 19-Nov-2021 10:52
    This message was posted by a user wishing to remain anonymous


    This is very good forum and getting so much valuable information here. :)

    I would like to know how medical device industry is handling when it comes to mixed lots within shipper (unit cartons with different lot numbers) which is a saleable unit. I read in this forum some indicate mixed lot on shipper label . What other options we have? As this is a saleable unit, lot number is required on shipper label. Is there anything in UDI regarding this?

    Thank You!

  • 2.  RE: Mixed lots within shipper which is saleable unit

    Posted 22-Nov-2021 04:56
    Hello Anon,

    The terminology you are using is introducing a bit of confusion and may have to better describe the different packaging levels which constitute the product.  However, will try give some information.  Most regulations do not have any requirements regarding the shipper for mixing products, mixing lots, or even medical/non-medical products as this is the "shipping box."  Now if the final carton box is also the shipper, this can also cause some confusion to an external auditor reviewing the packaging/shipping of the product.  My recommendation is internally, clearly describe in the technical documentation the different packaging levels, labelling requirements, and how shipping occurs.  If indeed the final carton box with mixed products/mixed lots are also considered the shipper, this should also be clearly described as to what would be considered the shipper.  Also make sure to include some rationale or justification internally in the technical documentation, why this is would be ok.  Because traditionally the shipping box is just that, a shipping box.  There are different ramifications on using this approach such as transport and shipping validation, UDI, and traceability of products.  I have done this before personally where the "main product" was carton box and shipping box, where we also put other products in there as well.  Because the carton box was also the shipper, we did decide to put the UDI on the carton/shipper and there was a label on the carton/shipper which described all the products inside the carton box as well.  You will not find a clear description of this in a regulation, but like many things in medical devices there are different ways to do things - just make sure you clearly document what you are doing and how it meets the requirements.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs