Let’s have a quick glance back at the tragedies of the pharmaceutical industry which reveal the importance of continuing compliance with current good manufacturing practices (cGMPs).
BCG Vaccine Deaths
In 1930 the Lubeck catastrophe occurred that also cast doubts on the safety of the BCG Vaccine. The BCG or Bacille Calmette-Guerin is a vaccine for Tuberculosis (TB).
In the German city of Lubeck 251 infants were given BCG that came originally from the Pasteur Institute in Paris, but it was prepared for administration in the TB laboratory in Lubeck.
Seventy two of the children developed TB and died within a year as a result of the disease, a further 135 developed clinical tuberculosis and only 44 survived.
Investigation Findings
A subsequent investigation carried out by German TB experts, revealed that the vaccine had become contaminated with the distinct virulent human strain during its preparation at a local laboratory.
Two people who had worked in the local laboratory were sent to prison in 1932 for “bodily injury due to negligence.
Thorough investigations following this incident revealed that batches of the vaccine were contaminated with the so-called ‘Kiel’-strain
Lessons Learned
So what GMP lessons can we learn from this?
The batches of vaccines should have been tested for identity, purity and safety, according to written and approved standard operating procedures, before releasing them into the market. Moreover, the local laboratory responsible for the contamination event needed to be operating under GMP conditions and should have been inspected prior to distribution.
