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Problems happen in work and in life.  Problems also happen within any quality system.

GMP requires problems to be dealt with correctly:

any deviation  … should be avoided as far as possible.  If a deviation occurs, it should be approved in writing … (EU GMP Chapter 5 – clause 5.15).

And, to find and deal with the root-cause of the problem:

“an appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems … In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those … (EU GMP Chapter 1 – clause 1.4xiv). 

So, it is important that we have an appropriate approach for dealing with problems.  Problems are often referred to as incidents, non-conformities and/ or deviations in many organisations.  What is needed is to deal with these in a way that proves that you have got to the root-cause of the problem and have taken the appropriate action to deal with this correctly.  Readers should also refer to our other article on CAPAs.

In order to prioritise dealing with problems (incidents, non-conformities and/ or deviations) target dates are often given for dealing with them. In many organisations, I have seen nominal targets of 30-days allowed to deal with all non-conformities.  Whilst fixing a date to deal with problems is a good thing, having a “one-size-fits-all” timeline often leads to more problems.  The issue is that, in order to deal with a problem correctly, you often need to gather data to prove that any actions you have taken have actually dealt with the problem for good.  If they haven’t, further actions will be needed, often taking additional time.  To ensure that you have truly fixed a problem for good often takes time, and may take more than 30-days (for example).  Adding a nominal target for dealing with all problems (such as 30 days) often results in two things.  Firstly a rush of activity on days 28, 29 and 30 trying to find a solution to the problem.  This is then often accompanied by quick fixes (corrections) rather than true corrective actions that get to the reasons why the problem occurred coupled with supporting evidence that the problem has been dealt with for good.  Whilst I agree with the need to set a target date for dealing with any problems, I believe that any dates applied should be based on a case-by-case basis considering the risks involved.

 What is your personal experience on timelines for problem resolution in GMP? Please leave a comment. 

You may also be interested in our GMP Problem Solving course.


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 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.

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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