Today (7th March 2012) is the 40th anniversary of one of the most infamous pharmaceutical disasters. Commonly known as the Devonport Incident, this problem concerned the release of non-sterile dextrose infusion bottles onto the market. 
It is thought that this incident cost the lives of 5 people. Whilst much has been written on this article in the past, today is a worthwhile reminder of the importance of Good Manufacturing Practice to protect patients from poor quality medicines and why the efforts we put in at work mean that fortunately problems like this are extremely rare.
The incident first hit the newspapers on the 7th March 1972, although the batch was manufactured in May 1971. The front page of the UK’s Daily Telegraph (below) captures the incident from the public’s viewpoint. Click here for a PDF of the article featured above – Devonport incident.
This later lead to a UK Government enquiry into the incident, which is summarised in the Clothier Report (July 1972). In this report poor operational practices surrounding the final sterilisation autoclave were blamed for the problem. The report is very difficult to get hold of and I have yet to see a copy on the web. It is a very interesting read if you can get your own copy. The final conclusions of the report are a sombre lesson to us all:
“The committee considers that too many people believe that sterilisation of fluids is easily achieved with simple plant operated by men of little skill under minimum supervision, a view of the task which is wrong in every respect.”
See the comments below for further thoughts on this topic.
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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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Whilst not denying that the death of five people is not devastating to the people concerned, and those they left behind, I would hesitate to call this “one of the most infamous pharmaceutical disasters”. It had impacts, sure, but compared with the heparin, propylene glycol, melamine, PIP breast implants issues that we have had, the actual direct effect was minimal.
Perhaps the sole distinguishing factor here was that the people who caused the Devonport incident believed that they were doing the right thing, because it was “the way it had always been done”. The examples I give of course concerned deliberate flouting of rules or even downright criminality.
The major outcome of Devonport was the need to PROVE that your equipment is functioning in the way that you intended it to function, and that people operating it had to be properly trained. In other words, the entire modern validation industry was spawned by this series of errors.
(And I too would love for someone to digitise the report and make it more widely available!)
Hi Chris, thanks for your comments which are welcome and much appreciated. Whilst there have been more significant and more recent incidents (as you state) my only real reason for mentioning this today is that is an anniversary of an event often referred to during my (and others) GMP and sterile products training courses. Dominic
Hi Dominic – interesting anniversary item! Going on my dictionary’s definition of ‘infamous’ as “having a bad reputation, notorious” then I would agree that Devonport is right up there. When I did my QP training a decade ago it was brought up relentlessly – certainly more often than any other industry incident.
Perhaps as Chris states, it has gained a prominence out of proportion to other industry disasters in terms of impact (although not a GMP issue, you could add the estimated 30,000 excess deaths associated with Vioxx to the list of ‘worse’ industry incidents), but it still jars to describe any fatal patient outcome as minimal, even if comparatively that is the case. The fact that it all happened here in the UK may also make it more keenly felt.
I’m sure I tracked down a web version of Clothier once, but of course I can’t find it now. However, while preparing some training slides recently I did stumble on this exhange in the House of Commons after publication of Clothier, which I think is also interesting. In the space of a few minutes debate, they covered pharmacovigilance, the limitations of inspection and product sampling regimes, CAPA, good practice guides, regulatory sanctions, ineffective recall (about 170 contaminated bottles were never accounted for), and a fine grasp of the concept of QA!
http://hansard.millbanksystems.com/commons/1972/jul/12/dextrose-solution
Thanks for this Mark. An interesting addition. Thanks for the link too.
http://www.pcc.nhs.uk/the-clothier-report
Many thanks. I will update the post. Dominic
Actually – that is not it. Thanks for trying. Dominic
Thank you – but this is not it. Dominic
I’m still using Devonport as a case study in the GMP training courses that I provide – useful at so many levels.
I have no professional input really in this debate . But find it very difficult, for me it’s a 44 year anniversary I am one of the children mention in the Telegraph.
At first I was a little up in arms about some comments on here but I realise that was just a personal reflex reaction on my part . I believe what makes this infamous is nobody will ever know the real death count missing bottles and cremations and all?
But I have no doubt at all my Mothers death was the alarm that recalled some bottles and prevented further deaths.
Also I met dentist while on holiday in Argentina that knew of The Evans Medical Devonport Incident which at the time I believed bizarre .
But after reading this here it has made me realise how important this incident this was.
Gillian Smith (Myatt)
Thank you for contacting us Gillian – fascinating comments.