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Authority for Justice and Consumer Protection

Apply for a certificate of compliance with the principles of Good Laboratory Practice

"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.

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Detailed description

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.

 

Information

Prerequisites

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

Documents required

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
  • List of GLP studies already conducted
  • list of standard operating procedures
  • organizational charts
  • List of all standard operating procedures (SOPs)
  • Directory of Computer-Aided Systems
  • SOP on the general procedure for creating, approving, amending, distributing and archiving the SOPs

(Agreement after preliminary discussion)

Please note

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.

Deadlines

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.

Procedure

  • 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.

Processing time

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

Fees

Fees apply. The amount of the fees depends on the time required for the preliminary and main inspection and the preparation of the report, if necessary with the involvement of other experts and assessors. You will receive a cost assessment notice, which will also show any expenses incurred.

Legal remedies

Contradiction

Legal basis


  • §§

  • State Ordinance on Administrative Fees (General Fee Tariff), Tariff Item 2.3.1 - VwGebV.

Links on the Internet

Address and contact information

Authority for Justice and Consumer Protection

Occupational Health and Safety

Mon-Fri 10am-1pm, Thurs 2pm-4pm

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Keywords: Laboratory according to GLP Standards for laboratories GLP certificate

Last updated: 29.04.2025