Hello good people of the world! Today’s post is about Corrective Action / Preventive Action, typically referred to as CAPA. CAPA is an integral part of any Quality System, and certainly one of the first things an agency will look at in any audit.
There is a ton of good information out there already on CAPA, including FDA’s own guidance from 2014.
I’ve personally used a few software packages for CAPA management, including MasterControl and Oracle’s Agile, among others, but have not seen any standouts.
The key points of the CAPA program are:
Issue identification, i.e. ensuring the issue is truly understood and well documented
Root cause analysis, i.e. identifying the root cause of the issue
effectiveness check, i.e. verifying actions have actually resolved the issue
What tips have you learned from your CAPA program? Comment below.
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Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.
Of note is the increased guidance around the use of quality risk management principles.
The revision will come into affect in March 2015.
What do you think of these changes? How will you adjust your quality program, if at all?
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Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.