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.
Also, find out more about how to ideally avoid and, if necessary, deal with problems on our 2-day 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 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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