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  • 1.  Address change and Quality Plan

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2021 15:33
    This message was posted by a user wishing to remain anonymous

    I would like to create a quality plan triggered by an address change.  (Legal and physical addresses are the same including production) 
    I am looking for some advice about what to include in the plan. 
    to make sure I won't miss anything. 
    Many thanks,


  • 2.  RE: Address change and Quality Plan

    Posted 10-Sep-2021 17:45
    Hi Anon.

    If I understand correctly - the location for production isn't changing and the legal manufacturing site address isn't changing.

    Then which address is changing, exactly? It's hard to give advice without knowing the details of the change.

    ------------------------------
    Hiral Dutia
    Regulatory Affairs Manager
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Original Message


  • 3.  RE: Address change and Quality Plan

    This message was posted by a user wishing to remain anonymous
    Posted 14-Sep-2021 21:37
    This message was posted by a user wishing to remain anonymous

    Thanks, 
    Everything is changing as the legal manufacturer and the production site have the same address. they are located at the same address which is about to change.
    Original Message


  • 4.  RE: Address change and Quality Plan

    Posted 14-Sep-2021 22:45
    ​Some of the things to consider:

    • Where will existing inventory be stored, how long will it be stored, when and how will it be relabeled?
    • Will there be shortages before production is established in new location?
    • Will customers who already have product labeled with the old address be able to contact the manufacturer at the new address?
    • who will notify suppliers, authorized representatives, and other business partners, when and how?
    • List all the establishment licenses and product licenses that will need updating, with who how and when.
    • Documents that need updating - who/how/when - IFUs, brochures, websites, technical documentation files, facility maintenance and pest control procedures, etc.
    • IQ/OQ/PQ for reinstalled equipment.
    • Employee training with new workflows.
    • Updated process validations.
    • Review of significant changes, letters to file and/or submissions.
    • Scheduling ISO/QMS and notified body audits.


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    Anne LeBlanc
    United States
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    Original Message


  • 5.  RE: Address change and Quality Plan

    Posted 15-Sep-2021 07:06
    Add Regulatory Impact - You will likely need to submit a significant change to your QMS to your NB.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


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