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Missing raw data become a GLP exeption?



  • Joseph
    14/11/2020 19:16
    Dear RQA GLP committee, I really would appreciate your advice on the following: Should missing raw data in a GLP study be reported as a GLP exception within the SD statement of compliance Some examples would be: · No specific records of stock solutions preparation, only refers to be performed according to the analytical method/protocol. · No records of the temperature at which a stability has been performed · or, during the freeze-thaw stability, one of the freeze-thaw cycles was not recorded
  • RQA GLP Committee
    20/11/2020 09:37
    Dear Joseph, It would be up to the Study Director to document what was missing and record the impact to the study. If this impact was sufficient to call in to question the compliance of the study, then it should be documented in the GLP Compliance statement. Can you reconstruct the activities from other data? If, for example one necropsy form was missing from a 500 animal study and you had other information – in-life findings, tissues, histology forms etc then the study may not be considered to be impacted and would be compliant. However, if the purpose of the study was storage stability at a particular temperature and you didn’t have anything to confirm that temperature had been maintained then you wouldn’t have met the objectives of the study, and any conclusions may be unreliable. Ultimately the responsibility rests with the study director and any omissions, deviations and potential justifications should be assessed, and if data has gone missing then the circumstances should be investigated, and a CAPA initiated.
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