Regulatory Open Forum

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  • 1.  Contract manufacturing and warehousing

    This message was posted by a user wishing to remain anonymous
    Posted 16-Aug-2022 10:28
    This message was posted by a user wishing to remain anonymous

    We are a US contract manufacturer and packager. A potential customer is asking us to warehouse raw materials/ components. We do not manufacture their product. We do not distribute any products directly to market. Are we allowed to register and operate as a warehouse for them if we do not manufacture their material? No finished product would be stored or distributed.


  • 2.  RE: Contract manufacturing and warehousing

    Posted 17-Aug-2022 08:37
    Hello Anon,

    I think simply if you want to warehouse material there is no "registration" or anything which needs to be completed.  As a warehouse this would be a supplier to a medical device company regardless of holding finished goods, components, or raw materials.  Thus there would be the typical GMP aspects which would need to be applied, e.g. traceability, identification, control, temperature, storage, handling, etc.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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