Regulatory Open Forum

 View Only

  • 1.  Assay validation range versus spec

    This message was posted by a user wishing to remain anonymous
    Posted 28-Nov-2022 09:03
    This message was posted by a user wishing to remain anonymous

    New to industry, first time posting. Thanks in advance for any shared wisdom!

    Why might an agency want an assay validation range to be wider than a given specification? (agency commented that validated range too narrow).


  • 2.  RE: Assay validation range versus spec

    Posted 29-Nov-2022 09:36
    Anon, a quick reference on this would be ICH Q2(R1) Section II.5 on Range. Generally speaking, you'll need confidence in how far outside of a given spec the result may be, to a reasonable extent.

    ------------------------------
    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Assay validation range versus spec

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2022 11:05
    This message was posted by a user wishing to remain anonymous

    In short, because you have to have as much confidence in the accuracy of results that are at the limit of specification as within specification.  I recommend you follow ICH Q2 (R1) - it is a thorough description of the minimum data required to validate an analytical method and is widely accepted by global Agencies.  Validation of assay range is usually 80 - 120 %.
    Original Message


  • 4.  RE: Assay validation range versus spec

    Posted 29-Nov-2022 13:46
    The validated range needs to allow for OOS (out of spec) findings. As a result, the validated range must be able to accurately test not only the range intended by the specification chosen, but the validated range also needs to allow/test for "real" values falling either HIGHER or LOWER than the range of values intended). In other words, the "actual" value reported needs to be VALID even if OOS.

    ------------------------------
    Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
    President and CEO
    Frestedt Incorporated (www.frestedt.com)
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
    ------------------------------

    Original Message


Related Content