ARI accreditation success

GLP (Good Laboratory Practice) certification of ARI Preclinical Facility

18 May 2016

High quality work is important for successful research. The AO Research Institute Davos (ARI) is working hard to ensure high quality in our research projects and is very proud to announce that it has been awarded the official "Statement of GLP Compliance" from the Federal Office of Public Health, of the Swiss Confederation through Swissmedic (Swiss Agency for Therapeutic products) together representing the Swiss GLP monitoring authorities this week. This is a particularly important award as AO Research Institute Davos is one of only two academic institutes certified for GLP in Switzerland.

Recently AO Research Institute Davos was re-accredited by AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care) and is the only academic institute in Switzerland that has achieved AAALAC accreditation. AO Research Institute Davos was also recertified for ISO 9001 / ISO 13485 earlier this year.

All these accreditations demonstrate AO Research Institute Davos's commitment in fulfilling the highest standards in research.

GLP is an internationally recognized quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

AO Research Institute Davos is now able to conduct preclinical studies with potential customers and any partners in the AO network in the only Swiss GLP and AAALAC accredited institute. This is of special importance to the AO for the future approval of medical devices by the United Stated Food and Drug Administration (FDA). The FDA currently has a new guideline under review (General considerations for animal studies for medical devices) for preclinical studies, which will make GLP and AAALAC virtually mandatory for any submission to FDA.

The GLP certification is part of the AO Strategy Fund project "Strengthening AO's Preclinical Research" which AO Research Institute Davos thanks for its financial support of this accreditation initiative.

Director AO Research Institute Davos Prof Geoff Richards also extended his thanks to " vet, Stephan Zeiter and the preclinical team, our Quality Management head Ulrich Bentz and also the other AO Research Institute Davos groups involved on behalf of the AO Research Institute Davos, the AOEM and the AO FoundationB".

GLP Certification 2016.pdf

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