FHAIVE has a Good Laboratory Practice (GLP)* laboratory, and qualified personnel educated in GLP. All FHAIVE validation studies and regulatory toxicity tests are performed in compliance with GLP. FHAIVE follows GLP principles in all aspects. If a study does not require GLP and is not audited by authorities, FHAIVE conducts and documents the study in the spirit of GLP.
*Good laboratory practice (GLP) is a quality system that provides a framework within which non-clinical safety and environmental studies are planned, performed, monitored, recorded, reported and archived. GLP principles should be followed in studies that are used in the registration and regulatory acceptance of pharmaceuticals, industrial chemicals, biocides, food and feed additives, cosmetics and veterinary medicines. GLP fosters mutual acceptance of test data in different countries. GLP principles are issued by OECD as Series on Principles of Good Laboratory Practice and Compliance Monitoring. Other countries, such as USA and Japan have their own corresponding GLP-programs.
- The in vitro test methods developed in FHAIVE are validated to be reliable, repeatable and relevant for the intended purpose. After the scientific proof of concept and method optimization, the test method validation will be performed in compliance with GLP according to the guidelines of OECD and other international relevant validation authorities.
- FHAIVE validates also methods developed by other research groups, and performs routine testing on request under GLP. FHAIVE also provides guidance for other laboratories in test method validation, and can act as reference laboratory for testing methods developed by other laboratories.
- The safety tests are performed under GLP if the results are aimed to be included in the regulatory documentation
- FHAIVE has been accepted as a Reference laboratory for EURL ECVAM (European Union Reference Laboratory for Alternatives to Animal Testing, Institute for Health and Consumer Protection, IHCP, Joint Research Centre, Ispra, Italy). EURL ECVAM promotes and coordinates the validation of alternative methods to be accepted into EU and OECD guidelines. Before regulatory acceptance the internationally validated methods are evaluated by the expert groups and authorities of EU and OECD respectively. The present state of the alternative tests and their regulatory acceptance can be found at the following addresses:
OECD Guidelines for the Testing of Chemicals, section 4.
EURL ECVAM Validation & Regulatory Acceptance