GMP mistakes are costly

In the continual saga of companies making fundamental GMP mistakes, Gilead has recalled two lots of its coronavirus treatment drug Remdesivir because of the “presence of glass particulates.”

If only there existed international standards on visual inspection and there were a solid set of best practices on lyophilization.

Oh, wait there are.

But then Gilead has a multi-year track record in deficiencies in their testing and manufacturing processes. In all fairness, they are contracting manufacturing to Pfizer’s McPherson site…..oh wait that site got an FDA 483 in 2018 specifying significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.

We deserve better manufacturers. Companies need to take the quality of their products seriously. We are always improving or we are always one step away from the sort of press Gilead gets.