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good manufacturing practice (gmp)

The quality of a medicinal product can only be guaranteed if the entire production process is carried out in line with an accurately prescribed and controlled method. The medicines must always be produced and checked in accordance with:

  • the quality norms for the intended use and
  • the requirements of the authorisation for marketing the product

Good Manufacturing Practice or GMP is a quality assurance system for the pharmaceutical, cosmetic and nutritional product industry.

GMP certificate

In the Netherlands the Health Care Inspectorate (IGZ) issues a certificate – a GMP certificate – to the manufacturer when able to verify compliance with GMP guidelines. The Health Care Inspectorate is responsible for the surveillance and carries out inspections for GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice).

Under the authority of the European Medicines Agency (EMA) and the Medicines Evaluations Board (CBG) manufacturing practices of manufacturers in countries outside the European Union are also inspected.
If required, the Inspectorate will advise the MEB about the manufacturers from the authorisation dossier ( site-clearance). 

Where it is established that a manufacturer deviates from the GMP quality requirements the MEB in consultation with the Health Care Inspectorate (plus other European Inspection authorities) or EMA may decide to remove the specific manufacturer from the authorisation dossiers.  

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