GLP principles of good laboratory practice

Dockx Rhenus Archisafe works according to the principles of Good Laboratory Practice (GLP) at some archive locations for customers from the healthcare and pharmaceutical industries. In order to meet the very high quality and security requirements of these sectors in the area of document archiving, these archives and the head office have been certified in accordance with GLP - in accordance with Section 19b (1) of the German Chemicals Act. The safety archive sites in Munich-Karlsfeld, Frankfurt a.M., Leverkusen and Großbeeren are currently GLP-certified. The special GLP topics include the implementation of strict documentation requirements, increased security standards with regard to the storage and equipment of the archives and the use of computer systems. According to the motto “only documented things count”, particular emphasis is placed on complete documentation in terms of process execution as well as in the QM area. At the customer's request, it is possible to separate the documents and store them in a locked area. The archive management system used is validated in accordance with Gamp5. The special requirements are documented in a GLP manual. All Rhenus-owned GLP certificates are stored in an independent GLP archive (outside the GLP sites). A validated digital archive is used for the long-term storage of internal electronic GLP data. All employees at the GLP sites are trained in GLP requirements.