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.
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 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.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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