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  • 1.  Annual Product Review vs Management Review

    Posted 21-Nov-2016 17:44

    Hi,

    Is the annual product review in the drug world the same idea as a management review in the med dev world?  The reason I ask is because we are an OTC drug manufacturer looking into getting into medical devices and we've developed our quality system to have both an annual product review and a management review.  I understand that the contents are somewhat different but is the concept the same?  If it is the same, can we just hold one annual review and cover topics that would be covered in both the annual product review and management review?  Or should these two events be separate?

    Thanks,

    ------------------------------
    Joon Park
    Summit Pharmaceuticals
    Phoenix AZ
    United States
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  • 2.  RE: Annual Product Review vs Management Review

    Posted 22-Nov-2016 07:59

    Hi Joon

    Well, they are really different but have similar elements in that they are formal and documented and the APR looks at some systemic things, but Management Review is totally a systemic review of the QMS, with trending, review of complaints, CAPAs, systemic procedures, resources, etc.. And it is also used to assess if you followed your Quality Plan, and to consider new regulations or guidance and plans and continuous improvement.

    I would advise keeping them separate so something is not missed.

    But I have worked in both pharmaceuticals and medical devices, so I like to draw a comparison. As you add medical devices you could focus on some product specific things for each one during Management Review, but it will be systemically focused.

    There are similarities between pharma and medical devices, though some say not.

    Good luck!

    Ginger Cantor, MBA, RAC
    centaurconsultingllc@gmail.com
    715-307-1850




    Original Message


  • 3.  RE: Annual Product Review vs Management Review

    Posted 22-Nov-2016 09:24

    Hi Joon,

    The short answer is no, as Ginger indicated. Management Review for devices includes reviewing the safety, quality and performance of specific products [intrinsic design (safety and effectiveness via clinical performance), and produced quality] from a quality objectives perspective, to assess the suitability and performance of the quality system. Again, these product reviews are only a small subset of overall Management Review however. 

    Class III devices do have a similar annual review to the pharma annual product review process. For Class I and II devices, periodic product-related reviews outside of Management Review primarily fall within the Post Market Surveillance system. This includes reviewing active and passive feedback to support use of various quality/regulatory tools such as risk management and clinical evaluation reports. I have expertise in integrating pharma-device quality systems for combo product manufacturers. Please give me a call if you feel I can be of further assistance.

    ------------------------------
    Randall Wheeland RAC
    Principal Consultant - Medical Device RA-QA
    rlwheeland@yahoo.com
    (210)978-3083
    San AntonioTX
    United States

    Original Message


  • 4.  RE: Annual Product Review vs Management Review

    Posted 22-Nov-2016 10:38

    Hello Joon,

    As quality professionals we agree that the reviews are not the same. They arise, after all, from different regulations written decades apart. But their intents are similar and there is certainly no regulation that prohibits combining them. If we are concerned not only with compliance, but working together well and efficiently, the task of combining the reviews is important to consider. There are plenty of good concepts in both sets of rules that can be applied to the other products, drugs or devices. Combining reviews is not a trivial matter but doing so can help your company come to a better understanding of quality and strengthen itself overall.

    If it is your decision to proceed along these lines I would encourage you to be clear in the design of your procedures and records that you are meeting the requirements of different regulatory systems, even highlighting some of the main differences. It is important that everyone participating in the process have a basic understanding of why the system is designed as it is.

    Good luck.

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    David Ledwig, RAC, CQA
    Principal Consultant
    Practical Compliance, LLC
    ledwigd@practicalcompliance.com
    O (828) 862-8555
    M - (828) 508-6535

    Original Message