In the 1940’s, patients in several hospitals in the USA developed bacteraemia. As a result, 40 died and 448 got infected but survived.
Packaging Change
A Pharmaceutical company selling the intravenous (IV) solutions in one kind of packaging (shellac lined lid), changed to another type of packaging (plastic lined) on all IV bottles.
Investigation Results
All reported cases of bacteraemia were associated with the new plastic lined lids.
It was discovered that 40% of all plastic lined lids were contaminated which resulted in the bacteraemia outbreak.
Lessons Learned
So what GMP lessons can we learn from this?
All incoming packaging raw material should have been thoroughly tested by quality control (QC) before release for production. Also, proper quality control and assurance practices should have been established.
