Quality system

Eurofins MikroKemi has a quality system which is based on both ISO 17025 and GMP. Quality shall be an integrated part of everything we do and our commitment to quality assurance is total. 

Accreditation

Since January 1997 Eurofins MikroKemi is accredited by SWEDAC for elemental analysis of pharmaceutical substances.

GMP

Eurofins MikroKemi was for the first time inspected by the Swedish Medical Products Agency, MPA, in December 2006 and was awarded a GMP certificate. See certificate to the right. Get a copy of the certificate as a PDF here.

FDA

In February 2011 Eurofins MikroKemi was inspected by and approved by the Food and Drug Administration, FDA.

Audits

Internal inspections are carried out on a regular basis. Eurofins MikroKemi is audited annually by several domestic and international pharmaceutical companies.