Bescheinigung über die Einhaltung der Grundsätze der Guten Laborpraxis (GLP) beantragen

• § 19b Gesetz zum Schutz vor gefährlichen Stoffen (ChemG)
• Allgemeine Verwaltungsvorschrift zum Verfahren der behördlichen Überwachung der Einhaltung der Grundsätze der Guten Laborpraxis (ChemVwV-GLP)
• Laufende Nummer 24 Tarifstelle 1 Sächsisches Kostenverzeichnis (SächsKVZ)

Certificate in accordance with Section 19b of the Act on Protection against Hazardous Substances (ChemG)

"Good laboratory practice" is a quality assurance system that deals with the organisational procedure and the framework conditions under which non-clinical health and environmental safety tests, the results of which are intended to enable a risk assessment in an official procedure, are planned, carried out and monitored. It also includes the recording, archiving and reporting of the test

As a test facility or test site, you can apply for a certificate of compliance with the principles of good laboratory practice. You will receive this certificate after carrying out a so-called inspection procedure and fulfilling the specified requirements.

The extensive requirements can be found in Annex 1 of the Act on Protection against Hazardous Substances (ChemG).

Single point of contact

You can utilise the service of the Single Point of Contact for this procedure. They will guide you through the procedure, take care of correspondence with all the authorities responsible for your concerns and provide you with expert advice.

• Single point of contact
  Amt24 information

Application (original) including the documents requested therein

For the issue of a GLP certificate

• the tests to be performed must be tests subject to GLP according to § 19 a ChemG or a legitimate interest must be substantiated.
• the test facility or test site and the tests or phases of tests performed there must comply with the principles of good laboratory practice according to Annex I ChemG.

Note: A legitimate interest exists, for example, if a GLP certificate is required for exportable products, although there is no obligation to test in accordance with Section 19 a (1) ChemG.

EUR 1,109 to EUR 16,169

The body that issues the certificate checks the application documents and initiates the inspection procedure. It selects the GLP inspectors to carry out the inspection and determines the inspection management.

• The inspection is carried out in accordance with the guidelines of the General Administrative Regulation on Good Laboratory Practice (more precisely: ChemVwV-GLP).
• The inspection ends with the presentation of a short report (list of defects) at the final meeting.
• If necessary, further documents will be requested prior to the inspection.
• In the case of an initial inspection, a pre-inspection is usually carried out; in the case of repeat inspections, this is determined on a case-by-case basis.
• The inspection procedure is concluded with an inspection report. This describes the extent to which a test facility/test site complies with the GLP principles and from which test categories tests are carried out in accordance with the GLP principles.
• If all requirements are met after completion of the inspection procedure, the competent body issues the GLP certificate.

Note: If you have any questions about the inspection procedure, you can contact the body responsible for issuing the GLP certificate.

Once the inspection procedure has been completed, a decision on the application for a GLP certificate will be made within three months.

not specified

More details in the notice