Pharmacelsus’ GLP implementation exemplary for European CROs
Pharmacelsus obtained GLP-certification covering the complete portfolio in November 2008. The company is not only able to perform accompanying analytical services for clinical studies in addition to its preclinical services, but also decided to share its knowledge on the GLP implementation process with other laboratories. Thirteen scientists of the European Commission Joint Research Center came to learn more about Pharmacelsus’ solution for the implementation of a GLP system in an in vitro laboratory.
During a three days hands-on training, they glanced at the lab-life in theory and practice, especially focusing the GLP relevant implementation on in vitro toxicology and bioanalytics. The practical course provided the opportunity for staff of all levels to understand the importance and relevance of GLP compliance, and how to apply the requirements of GLP into their everyday work in an in vitro laboratory.
Pharmacelsus cooperates with ECVAM in the framework of an international pre-validation study in the field of human metabolism and toxicity which is supervised by ECVAM.
Pharmacelsus holds the statement of GLP compliance for categories 2 (toxicity studies), 8 (analytical and clinical chemistry testing) and 9 (other studies: pharmacodynamic, pharmacokinetic, metabolical and toxicological testing). Because of the GLP status, the company is now able to perform accompanying analytical services for clinical studies in addition to its preclinical services.
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