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The same SOP Deviation ( Temp range) on multiple studies



  • Anon
    16/09/2019 09:49
    For the same SOP deviation (reporting process & already rectified) , that occurred on multiple studies ; - should each study have it's own SOP Deviation for the study master file? (It was not a study plan/Protocol Deviation) - can one General deviation be added for all applicable studies - explaining the deviation /impact & the actions already taken for the period/timeframe ? Thank You
  • anon
    16/09/2019 10:31
    I would have thought that this is up to your SOP on SOPs, and your SOP deviation procedure and SOP group. Document in your risk assessment
  • RQA GLP Committee
    20/11/2019 15:53
    Dear Anon, This would depend on how you intended writing one deviation that covered multiple studies. To assess the impact for multiple studies sounds difficult and therefore it would be more appropriate to document for each study, but as Anon says, if this is detailed in your SOP then you have an answer. The usual way of dealing with this type of event would be to write an SOP deviation then make a controlled copy for the SD of each affected study to add their study specific assessment of the impact. This controlled copy would be placed in each study file.
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