CAPA effectiveness checks

[Orr]

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!

[Stephen-Grayson]

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.

[Samia]

Thank you Stephen.