ICH - GCP Guidelines for Clinical Trials. Guidelines : ICH. The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.
Quality Guidelines Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Safety Guidelines ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. GLP, GMP & GCP regulations. Reference documents - EU Legislation - Eudralex. Navigation path News and updates on pharmaceuticals EU Legislation - Eudralex The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union".
Glp-handbook.