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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. 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.

Process flow

  • Application
  • Checking the completeness of the application documents
  • Inspection preparations including provision of documents from the applicant to the inspectors
  • Inspection
  • Decision by decision

Competent authority

The responsibility lies with the GLP control centre of the central support centre for air pollution control, noise, hazardous substances and incident prevention (ZUS LLGS) in the Hildesheim State Trade Inspectorate.

This procedure can also be handled through a "point of single contact". The "Point of Single Contact" is a special service offered by the municipalities and the state for service providers.

Requirements

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
     

Which documents are required?

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

What are the fees?

For the issuance of a GLP certificate:

  • The amount of the fees is - in accordance with Annex 1 to § 1 paragraph 1 General Fee Schedule of the State of Lower Saxony No. 21.1.1 - depending on the time required. However, at least 300.00 EUR will be charged.

For GLP inspection:

  • The amount of the fees results - according to Annex 1 to § 1 paragraph 1 General Fee Schedule of the State of Lower Saxony No. 21.1.2 - depending on the time required. However, at least 900.00 EUR will be charged.

Any expenses incurred will be shown in the cost determination notice.

Annex 1 to § 1 paragraph 1 General Fee Schedule (AllGO)

What deadlines do I have to pay attention to?

There are no legally prescribed deadlines to be observed.

Processing duration

An application for a GLP certificate will be decided within a period of 3 months after completion of the inspection procedure.

Appeal

Opposition - see information in the notices

What else should I know?

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

Source: Serviceportal Niedersachsen (Linie6PLus)

Further Links

Single points of contact of the state of Lower Saxony, Single points of contact of the countries of Europe, advice and assistance for EU citizens and their families.