Harmonization of the German GLP compliance monitoring programme

In order to harmonize and further develop GLP compliance monitoring in Germany, the GLP Federal Bureau participates in the committee “GLP and other quality assurance systems” (External Link:https://www.blac.de/Mitglieder-41-Ausschuesse-404.html) of the Working Group Chemical Safety of the Federal Government and the Federal States (BLAC). The BLAC is a working committee of the Conference of Environment Ministers (UMK) and was founded with the aim of ensuring that the implementation of chemicals legislation, which also regulates GLP, is as harmonized as possible in the Federal Republic of Germany (Section 20b German Chemicals Act). In the BLAC AS GLP, criteria for harmonized enforcement are ensured, corresponding administrative procedures are coordinated and solutions are developed for questions of interpretation and implementation of the GLP principles. In addition, UMK mandates on GLP issues are processed.

The working group is made up of representatives from:

- All GLP compliance monitoring authorities of the federal state

- Federal Ministry for the Environment, Climate Protection, Nature Conservation and Nuclear Safety (BMUKN)

- GLP Federal Bureau at the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment)

- Representatives of the German receiving authorities are also invited to the meetings

The working group has already drawn up consensus documents, recommendations and guidelines on various key topics (External Link:https://www.bfr.bund.de/ueber-uns/einrichtungen-am-bfr/glp-bundesstelle/glp-publikationen/).

There are additional offers for nationwide training and harmonization at inspector level, such as a national workshop for GLP inspectors organized by the GLP Federal Bureau, which takes place approximately every two years. If required, the German GLP monitoring authorities also organize online courses on current technical issues, which are open to all German GLP inspectors.