Good Laboratory Practice (GLP) defines requirements for a quality assurance system for non-clinical safety tests. Before new chemical substances can be brought to market, the potential hazards they pose must be thoroughly researched and evaluated. The GLP principles are therefore the basis of all non-clinical safety tests, the results of which must be submitted to the responsible authorities as part of the relevant procedures.
First and foremost are the internal GLP audits in our own testing facility. There are basically three GLP audit types:
In addition to these internal GLP audits, the performance of external GLP audits at suppliers of the test facility has also become increasingly important.
Conversely, GLP test facilities are often themselves the subject of external GLP audits because they are used as contract laboratories for other companies.
In the area of GLP we offer the following audit types:
- pre-clinical study protocol
- study conduct
- preclinical study report
- internal systems (e.g. facilities, equipment, SOP management, archiving)
- external systems (including CRO, bioanalytical lab and software provider)
- bioequivalence studies
- method validation (e.g. microbiological, analytical).
We would be happy to support and advise you individually as part of the implementation of your audit/audit program.