The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.
The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
The US Food and Drug Administration backs pyrogen and endotoxin testing recommendations developed by the USP and AAMI, but has issued a Q&A to set out the regulatory perspective
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”
Cambrex has launched a new system for stripping out bacterial
endotoxin from protein production systems that it claims is
associated with less product waste than current procedures.