Mapping the risks in GMP inspections

The Italian Medicine Agency (AIFA) informed all manufacturing sites and importers of active substances that the API Inspection Unit is mapping the risks in the frame of the planning periodic revision inspections in order to establish the appropriate interval for the inspections through a risk assessment.  The validity of the GMP certificate will be established based on such inspection intervals. The certificate will have a duration consistent with the assigned re-inspection interval. AIFA reserves the right of assessing the risk profile again, following the inspections after the periodic revision, with consequent update of the GMP certificate, whose duration could therefore be changed based on the possible variations of the risk profile. Before each inspection for the periodic revision, the sites shall fill in a specific form and send it to the API Inspection Unit, including essential information on the site.