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MHRA Guidance on the use of GLP Study Report Amendments



  • Ian
    21/09/2020 14:24
    In a ‘full form’ report amendment the MHRA guidance states that updated SD and QA statements should be included. Where the original SD is no longer available, could Management instead sign a short statement covering the additions/ changes and include this in the 'full form' amended final report in addition to the original SD statement? Management would be much more comfortable with this approach, as although multiple pages are affected none of the scientific detail in the report is affected therefore they see the original SD statement as still being appropriate. Are there any obvious reasons why this would not be acceptable? I note that the MHRA guidance does state that "other options may be acceptable" but I wondered if anyone had any thoughts on this example or any experience of using slightly difference approaches to the options detailed in the guidance.
  • RQA GLP Committee
    19/11/2020 14:32
    Dear Ian, This has been acceptable to the MHRA. It depends what your SOP says, but your other option would be to appoint a new SD and have them sign the compliance statement. It should be made clear who is signing the statement, and why it isn't the SD, if it is not the SD.
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