Q: How does FDA view long time-frames — say, three to six months, or even longer — for keeping a CAPA open? And if it takes a long time to verify the effectiveness of a particular remedy, would FDA challenge us for being slow in CAPA closure?
A: If you can demonstrate you have a logical plan and a realistic schedule for closing the CAPA, FDA usually gives you a good bit of latitude.
In my experience as an FDA investigator and as an independent auditor, I’ve seen many instances where a CAPA has been open for a long time because of some unique circumstance. The solution is to prioritize each CAPA and establish a specific schedule to resolve it. From FDA’s perspective, that’s a very important concept: fix the problem according to the time-frame you establish.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]From FDA’s perspective, it’s important to fix the problem according to the time-frame you establish.[/pullquote]
It’s when you establish no schedule at all — or allow things to linger without attention — you get in trouble with the Agency.
In some cases, even a temporary fix is good. For example, the real fix may a lengthy engineering solution, but meantime you can issue instructions or warnings telling customers how to use the product safely. Then of course you must follow through and actually fix the problem — again with a documented plan and schedule for CAPA closure.
Do your failure investigation, work as efficiently as you can, and remember to record what you do. Don’t let FDA assume you’ve neglected a problem when in fact you just haven’t documented the schedule and status of an on-going investigation.
Answered by Martin Browning, President and Co-Founder, EduQuest (22-year veteran of the U.S. FDA, including serving as an expert field investigator, and co-developer of FDA’s Quality System Regulation, also known as the QSR). For further training on FDA’s expectations for CAPA systems, plan to attend EduQuest’s class called The CAPA Clinic: Effective CAPA Systems, Failure Investigations, and Complaint Management.