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  • 1.  Timing of Manufacturing within Design Control

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2018 10:02
    This message was posted by a user wishing to remain anonymous

    Ladies and Gentlemen,

    I am new to Quality & Regulatory, and I am having trouble reconciling when manufacturing of products should occur within the context of Design Input phase, Design Output phase, Design Transfer phase, and Design Validation phase.  Do I need to have all my design inputs translated into design outputs, and have those outputs verified and validated before I create the Device Master Record?  When should I file for FDA clearance after the Design Transfer phase, after the DMR is created or after process validation has occured?   Help!

  • 2.  RE: Timing of Manufacturing within Design Control

    Posted 16-Jan-2018 14:20

    In order to create a FINAL DMR, you will need to complete the design verification and validation (V&V) stage. However, you can start to create a DRAFT of your DMR on an earlier stage while taking into consideration that changes might be introduced based on the V&V results and the subsequence need to make changes in the product design.
    the 510(k) notification can be submitted upon completion of the verification and validation stage (since you'll need the results of the V&V stage in order to demonstrate to the CDRH that the device is safe and effective for its intended use. 


    Tal Bresler, PhD.RAC

    Toronto, On, Canada

  • 3.  RE: Timing of Manufacturing within Design Control

    Posted 16-Jan-2018 20:39
    Manufacturing is after design transfer (design transfer is more or less the creation of the manufacturing process) and usually before design validation (design validation uses initial production units, lots, or batches - in this case manufacturing is before this - or their equivalents).

    The DMR is the "cake recipe"for the manufacturing of the design. You need to have it after design verification (which confirms that the design output meets the design input requirements).

    FDA clearance is after design validation (and process validation, which is another topic, is during design transfer and thus before design validation).

    Marcelo Antunes
    Regulatory Strategy Consultant
    SQR Consulting
    Sao Paulo

  • 4.  RE: Timing of Manufacturing within Design Control

    Posted 17-Jan-2018 04:41
    Remember too that the DMR will also contain the process parameters, the manufacturing work instructions etc.  And where is in that we develop and confirm our process parameters?  During our process validation.   So our DMR can not be fully complele till we are finished our PV as well.

    another way to think about it is to expand  the cake analogy further. So your cake recipe is the DMR.  It not only contains the recipe,  but also the instructions for the oven and the settings for the oven.  Everything you need to be able to make the same cake  somewhere else!

    Sebastian Clerkin
    GMP Advisory Services

  • 5.  RE: Timing of Manufacturing within Design Control

    Posted 17-Jan-2018 10:16
    I want to add another wrinkle here. Obviously you can't have a "final" DMR until everything about the design is completed - inputs, outputs, verification and validations - of both process and design - though there is a bit of a "chicken and egg" challenge as to how to best manage those.

    However, when you "complete the DMR" is very different than "when you design your manufacturing process." Yes, it is possible to just design away and when you complete DV, "toss" the product to manufacturing and let them design the manufacturing procedures. Or, it is equally possible for your design engineers to say "here is how we made them, just do this" at that point. Neither method seems to work very well and both increase the likelihood that you will be unable to consistently make good product to the existing design.

    It is much better to design the manufacturing process in parallel to the product design, with give and take between designers as features and design decisions evolve. Sometimes, you can add tolerance to a design that makes the product much easier to build etc. In this methodology, your DMR is evolving the entire way, but "transfer" is much easier.


    Ginger Glaser RAC
    Chief Technology Officer