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Closure of deviations (GLP)

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  • Pauline Carr
    29/03/2019 11:17
    I am updating our deviation procedure which currently states that once an investigation into the deviation/incident is completed, the deviation is closed. However, I would like to update the procedure to state that any deviations which have associated CAPAs should be Approved after the investigation is completed but they will not be Closed until the CAPAs have been completed. I have tried to find definitive guidance on when a deviation should be considered closed but cannot find anything. In a previous GMP role, deviations weren't closed until Effectiveness checks had been completed, but that suggestion has not been well received! Does anyone working in a GLP facility have any information which would prove helpful? Thanks
  • RQA GLP Committee
    21/05/2019 16:08
    Dear Pauline The regulations do not currently include the mandatory requirement for CAPA, however, where a system is in place it needs to be robust and effective. You need to devise a process which is appropriate for your organisation. The MHRA require that there must be processes in place to ensure sufficient responses and actions to inspection deficiencies. The expectation would be that any study related deficiencies were closed before the final report was signed, but for facility/system findings whatever is deemed appropriate (and is appropriately justified) would be acceptable.
  • kirimC
    23/08/2019 08:43
    Great post, Good. kirim_kula@protonmail.com kirim.kula@yandex.com
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