Regulatory Open Forum

 View Only

  • 1.  GLP Regulations

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2023 08:59
    This message was posted by a user wishing to remain anonymous

    Hello everyone,

    I have a question that I would appreciate your advice on.

    we are an IVD medical devices company manufacturing lateral flow tests. do we need to comply with GLP regulation? 

    kind Regards, Asma 



  • 2.  RE: GLP Regulations

    Posted 11-Jan-2023 01:18
    Hello,

    Typically if you are making a finished medical device the answer would be no.  Good Laboratory Practices (GLP) are usually required for compliance of organisations doing testing of components, materials, or other non-patient related results, i.e. biocompatibility, sterilisation, shelf-life, animal, etc.  Depending on the IVD, there may be aspects of GLP to consider in the manufacturing and/or testing of the medical device, but this also is commonly applicable during design and development such as verification and validation.  This might not necessarily be applicable during routine manufacturing, though again unless there are involved laboratory tests being done in-house.  However, generally the manufacturing and testing of a finished medical device would follow GMP requirements.

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

    Original Message


  • 3.  RE: GLP Regulations

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jan-2023 09:20
    This message was posted by a user wishing to remain anonymous

    Hi Richard, 

    thank you very much for your reply. 

    Just to make sure that I got you correctly. So as a company designing, developing and manufacturing IVD medical devices that do no t involve use of animal, plant and microorganisms we still need to follow GLP at some stage of product design?

    Kind Regards, Asma
    Original Message


  • 4.  RE: GLP Regulations

    Posted 11-Jan-2023 09:39
    Hi,

    It depends upon the regulatory framework of country/region you are planning to launch the product. Generally following the regulation is enough until regulation itself demands GLP compliance. All laboratories either doing animal or human testing/research need to follow GLP through some guidance like 15189 or CLIA.
    Hope this helps

    ------------------------------
    Rahul Pandey
    PhD
    Lucknow
    India
    ------------------------------

    Original Message


  • 5.  RE: GLP Regulations

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jan-2023 09:09
    This message was posted by a user wishing to remain anonymous

    Hi Rahul, 

    thanks a lot for your reply.  Really helpful.

    Kind Regards, 
    Asma
    Original Message


  • 6.  RE: GLP Regulations

    Posted 15-Aug-2023 10:19
      |   view attached

    This presentation provides an overview of the OECD 's Mutual Acceptance of Data (MAD) framework, as well as the OECD Principles of Good Laboratory Practice. It is of particular use for countries who are considering becoming adherents to the MAD framework, which includes non-OECD countries. The framework ensures the quality of non-clinical safety studies and reduces duplication of testing. Please contact the OECD at ehs.contact@oecd.org for additional information.



    ------------------------------
    Aldwin Aldana
    Director, Clinical Quality Assurance (GCP)
    West Newton MA
    United States
    ------------------------------

    Original Message


Related Content