Name that Pharmaceutical Manufacturing Accident
February 5, 2016 11:03 AM   Subscribe

I remember there being a manufacturing process accident (I think pharmaceutical) where the temperature of the reactor was out of specification and then the product had the wrong properties. This accident happened a long time ago and in my mind had a role in helping shape GMP.

I am also open to other interesting examples of manufacturing process accidents because cGMP were not followed (or didn't exist in the place/time) of the small temperature change type variety. Also, I'd love for these accidents to have existing utube videos.
posted by Kalmya to Science & Nature (4 answers total) 3 users marked this as a favorite
 
The Devonport Incident?
posted by exit at 11:29 AM on February 5, 2016


U.S. GMP arguably originated in the 1962 Kefauver Harris Amendment to the FDCA, in the aftermath of the Thalidomide controversy. But that had less to do with manufacturing process control than it did efficacy and safety testing.

Are you thnking of the 1970s septicemia outbreaks that were traced to contaminated IV products? Or the EMS outbreak related to L-tryptophan production processes?
posted by late afternoon dreaming hotel at 12:27 PM on February 5, 2016 [1 favorite]


There's the example of people trying to make the street drug MPPP and instead making the neurotoxin MPTP. I remember a chemistry professor telling me that it was due to poor temperature control, but I can't find the documentation anywhere. Obviously not related to GMP, but maybe still interesting.
posted by pombe at 3:42 PM on February 5, 2016


I'm not sure of any specific incident, but if you're trying to research it you might want to look up ICH in addition to FDA.
posted by kamikazegopher at 12:19 PM on February 6, 2016


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