GMP inspections and GMP certificates

Proper production practices are part of quality assurance when making medicinal products. It ensures that the manufacturers always make and check medicinal products in accordance with the quality norms for the intended usage. This is what is known as 'Good Manufacturing Practice' (GMP).

The principles of GMP are defined in law and described in EU Directive 2003/94/EC. The Dutch Health and Youth Care Inspectorate (IGJ) carries out periodic inspections at all medicinal product manufacturers in the Netherlands. During those inspections, which often take several days, we check whether manufacturers are complying with the GMP guidelines. A GMP inspection is generally combined with a Good Distribution Practices (GDP) inspection.

GMP certificate, permit and site clearance

If our finding is that the GMP guidelines are being observed, we issue a GMP certificate. We also advise the Health Minister on applications to obtain or modify production licences. The inspectorate issues advice on request to the Medicines Evaluation Board (MEB) about manufacturers from the authorisation dossier (this is known as a site clearance).

GMP inspections for veterinary medicinal products

Together with the Veterinary Medicinal Products department of the MEB, the IGJ also carries out GMP inspections at veterinary medicinal product manufacturers. These are the holders of permits under the Veterinary Medicines Act. These permits can be requested from the Veterinary Medicinal Products department.