Compliance with the principles of Good Laboratory Practice: Application to obtain a certificate

Facilities and laboratories that wish to carry out tests or phases of tests under the conditions of good laboratory practice (GLP conditions) require a GLP certificate.

Facilities and laboratories that wish to carry out tests or phases of tests under the conditions of good laboratory practice (GLP conditions) require a GLP certificate. In order to obtain the GLP certificate, the test facilities or test sites must demonstrate that compliance with the GLP principles is ensured. In order to obtain the certificate, an application must be submitted.

The competent body shall receive the application and carry out a GLP inspection at the test facilities or test sites. If the test facility or site complies with the GLP principles, the competent body shall issue a GLP certificate.

Documents are required. These depend on the subject of the application. Please contact the competent authority.

Preconditions

Test facilities or test sites must demonstrably comply with the GLP principles.

These provide for precisely defined standards for

  • Organization
  • Staff
  • Premises
  • test and reference substances,
  • Operating instructions
  • Results reports and
  • Archiving
     

Hints

All national GLP publications, OECD documents and EU documents on Good Laboratory Practice are available on the website of the GLP Federal Office in the Federal Institute for Risk Assessment.

  • Good Laboratory Practice (GLP) - BfR

Related Links

  • ยง 19b Chemicals Act (ChemG)
  • Ordinance on responsibilities in the fields of occupational health and safety, immission control, explosives, genetic engineering and radiation protection law as well as in other areas of law (ZustVO-Umwelt-Arbeitsschutz)
  • Application
  • Checking the completeness of the application documents
  • Inspection preparations including provision of documents from the applicant to the inspectors
  • Inspection
  • Decision by decision

Responsible for the content
Lower Saxony Ministry for the Environment, Energy, Building and Climate Protection

Last update or date of publication
10.02.2022