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Thread: CAPA effectiveness checks

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  1. #1
    Forum Member
    Join Date
    Nov 2016

    CAPA effectiveness checks

    Posting on behalf of a colleague- who really should post this herself on the forum!!!

    Regarding CAPA effectiveness checks, would it be acceptable to say that we are monitoring over X months to ensure the incident does not recur? or would this be considered to be reactive rather than proactive?

    Many thanks!

  2. #2
    Join Date
    Jun 2016
    There is a requirement in EU GMP (Chapter 1) that CAPA and change controls are reviewed at a suitable time post implementation to ensure that the quality objectives have been achieved, and that there are no deleterious impacts to this or other areas of the operation. The timing of the review is usually determined on a case by case basis as due to usage; some may be frequent and some very infrequent. You need data to review the impact.

  3. #3
    Forum Member
    Join Date
    Dec 2016
    Thank you Stephen.

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