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mercoledì 7 marzo 2012

Anniversari: 7 Marzo 1972 - the Devonport Incident - le GMP


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 below - 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 internet. It is a very interesting read if you can get hold of a 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.”

Tratto da: http://inspiredpharmablog.com/2012/03/07/the-devonport-incident-7th-march-1972/#more-388

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