The quality system Good Laboratory Practice (GLP) defines the requirements concerning the performance of non-clinical safety studies. Before new material, substances or preparations can be placed on the market, their potential hazards must be comprehensively investigated and evaluated. The GLP principles thus form the basis for all non-clinical safety studies whose results must be submitted to the relevant authorities in view of the corresponding registering procedures.
To monitor compliance with regulatory requirements, audits of test facilities (premises with personnel and work units necessary for conducting studies) are required with the objective of determining whether the performance of non-clinical safety studies is in compliance with the requirements of GLP principles.
We will be happy to support and advise you individually regarding the implementation of your audit/audit program and can offer you the following:
Study based audits (Audit of a study to determine if all data, records, reports and other requirements are in compliance with the GLP principles):
- Study plan review
- Audits of the studies to be performed as well as applied processes
- Audit of final report
Facility based audits:
Audits of the infrastructure necessary for the performance of a GLP study (premises, equipment, SOP management, archiving processes).
In addition, we also offer audits of suppliers who provide products needed to perform GLP studies (e.g. IT service provider).