What are GLP inspectors and are they relevant in the genetic laboratory?

The term "GLP inspector" comes from the Chemicals Act. "Good Laboratory Practice (GLP)" is a quality assurance system that addresses the organizational processes and framework under which health and environmental safety tests are planned, conducted, and monitored, as well as the recording, archiving, and reporting of the tests. According to Section 19b of the Chemicals Act, the responsible state authorities must, upon request, issue a certificate of compliance with GLP to anyone who conducts GLP tests according to Section 19a Paragraph 1 of the Chemicals Act or who can credibly demonstrate a legitimate interest without being obliged to conduct the corresponding tests. This is the case if the test facility or test site and the tests or test phases conducted by it comply with GLP according to Annex 1 of the Chemicals Act. The inspection of the test facilities and the review of individual tests for compliance with GLP principles are carried out by the state authorities. GLP inspections are carried out uniformly throughout Germany in accordance with the ChemVwV-GLP (Appendix to 4.1) and the explanatory notes in the "Manual for Inspectors on Monitoring Compliance with the Principles of Good Laboratory Practice." The guide describes, among other things, the monitoring procedure for compliance with Good Laboratory Practice. The guide is intended to lead to nationwide harmonization of monitoring practices by the responsible state authorities. These authorities appoint the GLP inspectors and issue the so-called GLP certificates. The GLP inspectors appointed by the states are required to conduct at least two inspections per year and participate in annual training events, experience-sharing events, or GLP working groups in order to maintain sufficient professional qualifications. The GLP inspection is carried out in accordance with Appendix (to 4.1) to the ChemVwV-GLP and concludes with the submission of a short report (list of deficiencies) during the final meeting.

Anyone who falls under the ChemG can also receive a visit from a GLP inspector.