Home » WHO Launches Global Program for Inspections of Sterile Drugmakers
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.
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