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  • 1.  Global Harmonization Task Force

    This message was posted by a user wishing to remain anonymous
    Posted 25-Feb-2020 13:12
    This message was posted by a user wishing to remain anonymous

    ​​RAPS Members,

    Can anyone tell me, is there an updated version of the Global Harmonization Task Force, Quality Management Systems, Process Validation Guidance (Edition 2)?  Edition 2 is from 2004, yet I cannot find an updated version.

    Is there a better guidance document to reference for validation of medical devices? 

    Your expertise and assistance is greatly appreciated.

    Thank you in advance.


  • 2.  RE: Global Harmonization Task Force

    Posted 26-Feb-2020 04:08
    Dear Anonymus,

    the Global Harmonization Task Force is no longer active, it has been "replaced" by the IMDRF (International Medical Device Regulator Forum). The document you are referring to has not been revised since its publication. 

    To answer your question regarding which guidance documents to follow for validation of medical device, I think a clarification is needed. Do you need to validate a device or the manufacturing process used for "making" that device? The two processes are different and have different requirements.

    Regards.

    ------------------------------
    Alberto Poli
    Regulatory Affairs and Quality Manager
    Brescia
    Italy
    ------------------------------

    Original Message


  • 3.  RE: Global Harmonization Task Force

    Posted 26-Feb-2020 08:45

    All current (and past) GHTF documents are available for free at www.IMDRF,org including the current PV document which is the 2004 document you have. 

    Look under "Documents" and you will find "GHTF Final Documents". The document you want is among the "GHTF Study Group 3-Quality Systems" documents. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


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