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The GLP Principles set out the requirements for the appropriate management of nonclinical safety studies. This helps the researcher to perform his/her work in compliance with his/her own pre-established scientific design. GLP Principles help to define and standardise the planning, performance, recording, reporting, monitoring and archiving processes within research institutions. The regulations are not concerned with the scientific or technical content of the studies per se. The regulations do not aim to evaluate the scientific value of the studies: this task is reserved first for senior scientists working on the research programme, then for the Registration Authorities, and eventually for the international scientific community as a whole. The GLP requirements for proper planning, for controlled performance of techniques, for faithful recording of all observations, for appropriate monitoring of activities and for complete archiving of all raw data obtained, serve to eliminate many sources of error.
Whatever the industry targeted, GLP stresses the importance of the following main points:
1. Resources: Organisation, personnel, facilities and equipment;
2. Characterisation: Test items and test systems;
3. Rules: Protocols, standard operating procedures (SOPs);
4. Results: Raw data, final report and archives;
5. Quality Assurance: Independent monitoring of research processes.
