Einhaltung der Grundsätze der Guten Laborpraxis Bescheinigung

• §§ 19a ff. ChemG
• State Ordinance on Administrative Fees (General Fee Tariff), Tariff Item 2.3.1 - VwGebV.

"Good Laboratory Practice" (GLP) is a quality assurance system under which non-clinical safety tests are planned, carried out and monitored. To have the tests recognized as GLP-compliant, facilities require a GLP certificate.

According to the Chemicals Act, non-clinical facilities require health and environmental safety tests for the approval or authorization of substances and preparations.
These security checks must also be carried out for registration, login or notification procedures.
They must be carried out in compliance with the principles of Good Laboratory Practice (GLP) and assess potential hazards to humans and the environment.
The principles of Good Laboratory Practice provide precisely defined standards for organization, personnel, premises, test and reference substances, work instructions, result reports and archiving. To obtain GLP certification, test facilities and test sites must demonstrate that they meet the GLP requirements.
Good Laboratory Practice aims to ensure that test results are internationally recognized and that animal testing is restricted.

Please submit the documents requested by the GLP Commission with your informal application:

• Organizational structures, organizational plans (company/GLP structure)
• Job descriptions, number of employees
• Description of the investigations for which the GLP certificate is requested
• Documents relating to the premises of the test facility or test site, for example building plans or floor plans, GLP area marked
• Test systems
• Organizational charts
• List of all standard operating procedures (SOPs)
• List of computer-based systems
• SOP on the general procedure for creating, approving, amending, distributing and archiving SOPs

As a test facility or test site, you must demonstrate that you comply with the GLP principles. These provide precisely defined standards for

• organization
• staff
• Premises
• Test and reference substances
• The use of computer-aided systems
• Work instructions
• Result reports
• Archiving

Fees apply. The amount of the fee depends on the time required. You will receive a notice of costs, which will also show any expenses incurred.

• You submit an informal application and submit it to the responsible authority.
• When you apply for the GLP certificate for the first time, your eligibility will be checked.
• Preliminary discussions and, if necessary, a preliminary inspection will take place.
• They provide the inspectors with all necessary documents to prepare for the inspection.
• During an inspection, the competent authority checks whether you comply with the principles of Good Laboratory Practice.
• You will receive an inspection report.
• If you do not yet comply with all the principles of Good Laboratory Practice, you will be given the opportunity to correct the deficiencies.
• You submit proof that the defect has been remedied.
• The responsible authority will decide on your application.
• You will receive the GLP certificate.

A decision on an application for a GLP certificate will be taken within 3 months after completion of the inspection procedure.

In order to remain in the monitoring program, an application for a new GLP certificate must be submitted regularly. The deadlines are agreed individually in the inspection reports.

On the website of the GLP Federal Office at the Federal Institute for Risk Assessment you will find all national GLP documents, OECD documents and EU documents on Good Laboratory Practice.

Contradiction

• Certificate of compliance with the principles of Good Laboratory Practice
• Compliance with the principles of Good Laboratory Practice: Application for a certificate
• Institutions and laboratories that wish to conduct tests under Good Laboratory Practice (GLP) conditions require a GLP certificate.
• To obtain the certificate, an application must be submitted and a subsequent inspection by the responsible authority.
• To remain in the GLP monitoring program, both the application and the inspection must be repeated regularly.

Justice and Consumer Protection Authority