Laboratory and quality control
The National Agency for Medicines monitors the quality of medicinal products on the market and their raw materials by laboratory testing. The samples to be studied are obtained from wholesalers or sampled during inspections in from pharmaceutical manufacturing plants, pharmaceutical wholesalers, pharmacies, hospital pharmacies and distribution centres for medicinal products.
For quality control, the National Agency for Medicines has a laboratory.
The quality system of the laboratories complies with the SFS-EN ISO/IEC 17025 standard.
The main methods employed by the NAM laboratory have been accredited by the Finnish Centre for Metrology and Accreditation FINAS. The accreditation decision and a description of the scope can be viewed at the FINAS website.
NAM’s laboratory is part of the European Network of Official Medicines Control Laboratories, coordinated by the European Directorate for the Quality of Medicines (EDQM) of the Council of Europe. As part of the network, NAM’s laboratory actively participates in the European quality control cooperation and in quality control of medicinal products that have been granted marketing authorization under the centralized procedure. For further information on the Laboratory Network, see the EDQM website www.pheur.org.
NAM’s laboratory also co-operates with other authorities.