Accreditation of the Danish Medicines Agency's laboratory

01 June 2011, Updated 21 February 2019

The Danish Medicines Agency's laboratory is accredited according to DS/EN ISO/IEC 17025. The accreditation is granted by DANAK (Danish Accreditation and Metrology Fund). This means that the laboratory's analyses of medicines are conducted in compliance with established guidelines, and that the laboratory is supervised by DANAK.

The laboratory's scope of accreditation is: Testing of pharmaceutical products within the following areas: Biological, chemical and microbiological testing as well as ionising radiation and radiochemistry.

The laboratory has a flexible scope of accreditation pursuant to a list of methods, with regard to parameters and area of testing. This means that the laboratory is accredited on an overall "technical level" (e.g HPLC, GC, TLC, etc.).

The laboratory has the possibility to vary the technical details of these methods depending on the tests performed.

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