By definition, Good Laboratory Practice (GLP) is a quality assurance system that addresses the organizational process and framework under which non-clinical health and environmental safety testing is planned, performed and monitored. The recording, reporting and archiving of the tests are an essential part of this. The German Chemicals Act (§ 19a) and Directive 2004/9/EC require GLP-compliant safety testing for the approval of new chemicals (e.g., pesticides) and pharmaceuticals. Such tests, divided into nine different test categories, may only be performed by state-certified GLP testing facilities.

The GLP testing facility of Fraunhofer IZI has been certified for testing category 9 "Safety testing of ATMPs - immunotoxicity / immunogenicity, biodistribution and tumorigenicity in vitro / in vivo" since 2009. In addition, the most recent audit of an ongoing toxicological study was carried out in order to additionally obtain testing category 2 "Toxicity studies". The responsible state authority, the Saxon State Ministry for Energy, Climate Protection, Environment and Agriculture, inspected all processes for this and certified compliance with the principles of good laboratory practice for this test category as well as of January 17, 2023.

As a result, the Fraunhofer IZI GLP testing facility is now officially authorized to perform GLP tests in testing category 2 "Toxicity studies" in addition to GLP tests in testing category 9 "Safety testing of ATMPs - immunotoxicity / immunogenicity, biodistribution and tumorigenicity in vitro / in vivo".

More information: GLP Test Facility