The Good Laboratory Practice (GLP)
Date: 22 April 2020
The Good Laboratory Practice (GLP) is a quality assurance system that deals with the organizational process and the framework under which non-clinical health and environmental safety tests are planned, carried out, as well as with the recording, archiving and reporting of the studies. However, GLP does not aim to make a statement about the scientific quality of a study.
The following GLP goals shall be achieved:
- Traceability of examinations through complete documentation
- Definition of responsibilities
- Clear organizational regulations
- Generation of data of adequate quality for the evaluation of a product
- International mutual recognition of data
Avoidance of multiple examinations
In order to maintain the quality assurance system, the 5 W method is used: Who has done what wherewith when why?
Everything that has not been documented formally is considered not to have been done.
As the GLP requirements are legal requirements, there are no self-certifications, but a government surveillance system with regular audits. SCC was officially re-certified as “GLP contract archive” at the last inspection 24th October 2018 by the “Landesamt für Umwelt Rheinland-Pfalz”. The legal foundations in Germany is “§19 of the German Chemicals Act” based on and the "Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004", based on the “OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring”, as well as the “OECD GLP consensus documents”.
Knut Gottfried