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.