Scheduling an inspection

Applicants will receive a list of queries after the initial assessment of their product application. Where confirmation of the GMP status is required, this will be reflected in the query letter. Upon receipt of the query letter, applicants can contact the joint GMP Inspections Coordinator and trigger the site inspection or GMP Desk Review, as appropriate.

Simultaneously, the joint Assessments Coordinator liaises with the joint GMP Inspections Coordinator to verify sites requiring inspection to support product applications already submitted and under review using the ZAZIBONA pathway. Applicants will be contacted by the Inspections Coordinator or lead inspector to plan the inspection, request relevant documents and facilitate a proforma invoice for the inspection fees. More details are contained in the Frequently Asked Section.