Many pharmaceutical firms have a system for dealing with CAPAs (Corrective Actions and Preventive Actions). This is an important system as it deals with problems that occur and should also be used to prevent future problems occurring too. Readers should also see a related post from January on how the industry has made a lot of mistakes on how it defines and uses CAPAs, and how this can lead to ineffective CAPA systems. Another problem of CAPA systems that I have seen comes from assigning a set date (usually 30 days) to close them all. This can cause more problems than it solves!
The setting of a date to close a CAPA is a good idea. It provides a target to work towards. However, setting a blanket “one-size-fits-all” date to close all CAPAs often causes further problems. This is what can happen if a set target of, say, 30 days is applied to close all CAPAs:
It might need to be done quicker
It may be that a CAPA is so significant that it may need to be dealt with immediately and not left to wait for a month!
It might be simple to do
It may be that it can be dealt with and closed immediately if done now – so why wait?
It might take longer than 30 days
This is my main concern – in order to effectively close a
We are all human
The final problem of establishing a set target (say 30 days), is that it can encourage little activity until Days 28, 29 & 30 and also can lead to quick-fixes on the final due date too!
Don’t get me wrong. I am not saying that there is no point establishing a due date to deal with CAPAs, nothing can be further from this. However, I firmly believe that each CAPA should be dealt with on a case-by-case basis, with timeframes, actions and responsibilities established with the key players involved at the time. Timeframes for actions should be based on the risks involved. Please let me know what you think.
This topic along with many others is covered in detail on our GMP Problem Solving course
Other posts related to this topic that you might like to read include
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
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Hi, right now I am trying to find a preventative measure to avoid human error in proofreading artwork for pharmaceutical drug packaging material. Basically would like to understand if there is a gold standard process out there or industry best practises? So this bit of research takes time so in order to take CAPA seriously I agree, it is case by case. But back to my original issue, does anyone have any experience or knowledge of such best practises? I am sure there are plenty software solutions but a recommendation or other options would be good. Thx
Comment from LINKEDIN:
“I agree with you Dominic.
Usually we establish a first 30 days timeline to receive a first answer to our report findings, that is a draft of CAPA. But when we agree and approve the CAPA, we define different responsibilities and timelines for each finding. So we could agree in solving a finding in one month and another in one year, according to the complexity of the corrective action to be implemented. One does not fit all.”
Posted by David Paoletti
Comment from LINKEDIN:
I totally agree with your in your approach about the setting of 30 days to close the DEVIATION, it is most effective to set up a time period to close de investigation to be performed and the pertinent root cause analysis, and of course, if investigation can not be finished in the assigned period of time it is a good practive and well accepted by Health Authorities to issue a memo explaining the reasons for the non completion along a plan to complete the investigation and an impact analysis of this delay on the deviation.”
Posted by Francisco Javier Mariano Lazaro
I’m also in total agreement.
We use a number of CAPA workflow templates that are designed to be used for different CAPA sources & risk severities (more stages up to 8P for the most severe, fewer for those that tend to be simpler). I take the advice of a senior GMP inspector in setting a 30 day limit for the investigation for the more severe CAPAs and then setting target dates for subsequent stages (RCA, Identifying Corrective Action, Implementing CA etc) I’m also quite keen on a containment stage for the more severe non compliances and often find that I need to allow those who want to race to the quick fix to do what they want to do as a Remedial Action or containment action then do more in depth investigation once the dust has settled a little, do a reflective RCA and produce the unpopular, suggested Corrective Actions.
It is at this stage that everyone seems to disappear and have to be dragged back to the table to be persuaded of the logic and wisdom of the Corrective Action Plan (strange how everyone thinks a CAP is a good thing but no-one wants responsibility for any of the actions). I get very hard-nosed about assigning responsibilities, time scales and success criteria for Corrective Actions, revisiting the CAP in meetings and going a level of management up to chase actions.
I also often find that it is worth waiting for some of the Corrective Actions to be completed & start showing benefits before suggesting further, less popular Corrective or Preventive Actions
Dominic – Your point of 30 day close out target for CAPA is a good one. GMP (and regulatory inspectors) expects that timely actions are carried out and completed whether investigations arising from deviations, corrective actions and actios to prevent re-occurence. So the question is how do we measure or assess that timely (appropriate and commesurate with the risks of not taking action) action has been taken.
One way is to measure completion against a planned target/completion date. In fact this is an approach I see more often. However, this can be an issue in that planned completion dates have a tendancy to be set too generously rather than “agressively” completing the action required. Note that by definition a corrective action is “correcting” an identified problem in GMP compliance and potentially patient safety.
Whilst some corrective actions actions to prevent re-occuance can take some time most however, can and should be resolved more quickly. These have a tendancy to be put off in order to deal with the longer to resolve problems. The FDA, due to its inspection style, discover these frequently resulting in warning letters. The “30 day” target date was I believe introduced to address this. However it is not a good measure and is clearly not effective as observations of exceeding 30 days are frequent. Mainly as generally most companies are trying to deal with lots of “CAPA”. In general they focus to much on the CA (corrective action) and not enough on the PA (action to prevent re-occurance). I have yet to see (there may be one but I have not seen it) in the pharmaceutical inductry a focus on the PA and measure to monitor repeat issues.
Thanks Dave – remember that PA is to prevent occurance and not recurrance.