GMP inspection
Good Manufacturing Practice is a component of quality assurance when preparing human and veterinary medicinal products. It ensures that manufacturers and importers of veterinary or human medicinal products always prepare and monitor according to the quality norms for the intended use. Good Manufacturing Practice is also known by its abbreviation, GMP. The principles of GMP are laid down in legislation and described in EU Directive 2003/94/EC.
On behalf of the Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN) and the VMPU, the Health and Youth Care Inspectorate (IGJ) conducts periodic GMP inspections at all manufacturers and importers of veterinary medicinal products in the Netherlands. During this GMP inspection, the IGJ assesses whether these manufacturers and/or importers comply with the current GMP guidelines.
Applications for a manufacturer's licence, i.e. a licence for the manufacture and/or import of veterinary medicinal products, are submitted to the VMPU. See also the Manufacturing page.
Before such a licence can be issued, a GMP inspection must be carried out by the IGJ. The VMPU will submit the request for scheduling a GMP inspection to the IGJ. Depending on the scope of the activities, the GMP inspection can take several days.
After assessing the inspected location, the IGJ will draw up an inspection report. The VMPU may then issue a GMP certificate depending on the outcome of the inspection (GMP level is sufficient or insufficient).