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Compliance with the principles of Good Laboratory Practice: Applying for a certificate


Facilities and laboratories that want 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 certification, the test facilities or test sites must demonstrate that compliance with the GLP principles is guaranteed. An application must be submitted to obtain the certificate.

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 GLP principles, the competent body shall issue a GLP certificate.

Process flow

  • Application
  • Checking the completeness of the application documents
  • Inspection preparations, including the provision of documents by the applicant to the inspectors
  • Inspection
  • Decision with notice

Competent authority

The responsibility lies with the GLP control centre of the Central Support Centre for Air Pollution Control, Noise, Hazardous Substances and Major Accident Prevention (ZUS LLGS) in the State Trade Inspectorate Hildesheim.

This procedure can also be handled by 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 GLP principles.

These provide for precisely defined standards for

  • Organization
  • Staff
  • Premises
  • test and reference substances,
  • Operating instructions
  • Reports on results and
  • Archiving
     

Which documents are required?

Documents are required. These depend on the subject matter 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 determined - according to Annex 1 to § 1 paragraph 1 of the General Fee Schedule of the State of Lower Saxony No. 21.1.1 - depending on the time spent. However, a minimum of EUR 300.00 will be charged.

For GLP inspection:

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

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

What deadlines do I have to pay attention to?

There are no legally prescribed deadlines to be observed.

Processing duration

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

Appeal

Objection - 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 at the Federal Institute for Risk Assessment.

Source: Serviceportal Niedersachsen (Linie6PLus)