WHO Launches Global Program for Inspections of Sterile Drugmakers

The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers.

The two-year pilot — which also includes inspection authorities from Australia, Canada, the EU and Japan — is designed to boost cooperation on routine inspections of previously compliant facilities in countries outside the program.

 “It is expected that the … observations identified by the inspection team and the preliminary conclusions of the inspection will be jointly agreed on-site by the inspecting authorities,” the WHO said.