Procedure descriptions
Apply for a certificate confirming compliance with the principles of Good Laboratory Practice
Good Laboratory Practice (GLP) is a quality assurance system that addresses the organisational procedures and framework conditions under which non-clinical health and environmental safety tests are planned, carried out and monitored, as well as the recording, archiving and reporting of the tests.
The Good Laboratory Practice quality assurance system was developed by the Organisation for Economic Co-operation and Development (OECD) to ensure the quality and comparability of test data from substance studies.
Responsible authority
In Baden-Württemberg, the LUBW (Baden-Württemberg State Agency for the Environment) is responsible for the monitoring procedure (Department 35: Chemical Safety).
Details
Prerequisite
Any person whose testing facility or testing site carries out non-clinical safety tests subject to GLP in accordance with Section 19a(1) of the Chemicals Act, or who can demonstrate a legitimate interest in accordance with Section 19b, may submit an application for the issue of a GLP certificate.
Under Section 19b(1) of the Chemicals Act, the competent authority shall then issue a GLP certificate, if an inspection procedure has established that a test facility or test site, and the tests or phases of tests carried out there, comply with GLP principles.
Procedure
- Test facilities in Baden-Württemberg that are required to comply with GLP must submit an application for a GLP certificate to the State GLP Office.
- The application is made using the application form and is submitted electronically to the State GLP Office.
- Once the application has been assessed, the State GLP Office puts together an inspection team comprising members of the Baden-Württemberg Inspection Commission, which carries out an on-site inspection of the testing facility or test site to verify that work is being carried out in accordance with GLP principles.
- If the inspection team is able to confirm that the testing facility and the tests carried out comply with GLP, the GLP Regional Office issues the GLP certificate by means of a formal decision.
Deadlines
There are no specific deadlines for the companies concerned when submitting their initial application. However, work subject to GLP requirements may only commence once the certificate has been received. Depending on the complexity of the case, the inspection process may take several months. The inspection process is only concluded once any identified deficiencies have been fully rectified.
The GLP notification specifies a deadline for resubmitting the application for the required follow-up inspections. The first follow-up inspection usually takes place after 1.5 years. Thereafter, depending on the outcome of the inspection, the deadline for the follow-up application may be extended to up to three years.
Required documents
The following documents must be submitted to the GLP Regional Office when applying for a GLP certificate:
- a fully completed application form, which can be downloaded from the GLP Regional Office’s website
- A diagram of the organisational structure of the (future) GLP test facility (e.g. an organisation chart)
- A diagram of the premises (e.g. building or room plans, floor plans)
- A list of all GLP-relevant SOPs
- Master schedule
- where applicable, a list of all test sites belonging to the GLP test facility
- where applicable, documents substantiating the legitimate interest
Costs
Fees are payable for the inspection and the issue of the GLP certificate; these are based on the amount of work involved and the current schedule of fees issued by the State of Baden-Württemberg.
Processing time
A decision on the application for a GLP certificate will be made within three months of the completion of the inspection procedure.
Miscellaneous
If you have any questions regarding the GLP monitoring procedure, please feel free to contact the GLP Regional Office:
GLP-BW@lubw.bwl.de
Legal basis
Chemikaliengesetzt (ChemG):
- § 19a Gute Laborpraxis (GLP)
- § 19b GLP-Bescheinigung
Release note
machine generated, based on the German release by: Umweltministerium Baden-Württemberg, 19.05.2026