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In the manufacture of any form of product it is inevitable that, from time to time, things will not go to plan.  Problems and deviations from normal practice are a fact of life, and in GMP this is permitted, as long as they are controlled and dealt with correctly.
Recent updates to EU GMP Chapters 1 and 8, on the Pharmaceutical Quality System and Complaints, Quality Defects and Product Recalls both have similar statements with regard to being careful about blaming the operator when a problem occurs:

In Chapter 8 it states:

“Where human error is suspected or identified as the cause of a quality defect, this should be formally justified and care should be exercised so as to ensure that process, procedural or system-based errors or problems are not overlooked, if present” (8.17)

shutterstock_396735082In other words – be careful of putting “human error” as the cause of a problem, without considering what caused the human to make the error in the first place.  I do work with some pharmaceutical companies that have banned the use of putting “human error” as the reason for a problem.  I think that this is a bit excessive, as we can all make mistakes, but here are a list of things that you might want to consider before we blame the human.

  • Was their training sufficient?
  • When where they last trained?
  • Was their training evaluated?
  • Has the job changed?
  • Has the environment changes?
  • Have procedures changed?
  • Are the procedures clear to the user?
  • What other tasks were they doing?
  • Were they tired?
  • What pressure were they under?
  • Were there any distractions?
  • Did they deliberately do it wrong?
  • Did they understand the ramifications of doing it wrong?

It will be worth thinking about these things in any problem solving and deviation investigation that you do.  If you would like further help with Problem Solving training then please have a look at this 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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