EN PL

GMP: ICH publishes New Draft Guideline on Genotoxic Impurities

07.03.2013
The ICH has published a draft guideline for comment on the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: \"M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk\".