Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women.
Birth Defects
It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children.
It was discovered that one molecule caused sedation which was the desired effect, whilenthe other enantiomer caused devastating birth defects known as Phocomelia.
Lessons Learned
So what GMP lessons can we learn from this?
Again, this was a GMP deficiency by not having adequate QA and QC programs. The presence of the unwanted molecules could have been detected using a validated assay.
The solution would have been to remove the undesired molecule by a validated purification process and assured by using a validated testing procedure which would have ensured a greater certainty of prevention and detection of bad product before it was released to market.
