The company Dextras, which was founded in the fourth semester, is a GMP-certified control laboratory. Furthermore it is GLP certified. The company tests samples from the cleaning validation, approval and validation batch under GMP conditions and accepts samples from pre-clinical (GCP) and clinical (GCLP) trials. There are only samples from the control- and bioanalysis accepted in this analytical laboratory.
This document is part of comprehensive quality training in consideration of legal guidelines and supports the training measures in this company. In this specification the requirements of SOP’s were characterized.