Laboratory of Fimea

Fimea has a laboratory that supervises the actions of the license holders in the pharmaceutical field by testing the quality of medicines on the Finnish market. The quality surveillance is performed in order to ensure the appropriate quality and safety of human and veterinary medicines.

The laboratory uses a selection of pharmaceutical, chemical, biological and microbiological testing methods. For each medicine, the tests are chosen to reflect the critical quality attributes affecting the efficacy and safety.

The laboratory also regulates the batch release of vaccines and blood or plasma derived medicines.

In addition, the experts working in the laboratory participate in the work of the European Pharmacopoeia in order to develop common standards for medicinal quality control. The personnel also provide expertise for inspections and marketing authorisation assessment.

The quality surveillance is funded by regulatory fees while the pharmacopoeial activities are funded by the state budget.

Laboratory Quality Standard

The laboratory adheres to the EN ISO/IEC 17025 standard.

The most important techniques used in the quality surveillance of medicines are accredited by the Finnish Accreditation body, FINAS, which has granted the laboratory a flexible scope accreditation (T170). In addition, the laboratory has been audited and approved by peer assessors (pdf) of the European Official Medicines Control Laboratory -network (MJA).