Since July 2014, when ICH M7 guidelines were implemented in the national regulations in the three ICH regions (Europe, United States and Japan), SAXOCON has delivered hazards assessments to pharmaceutical companies and biotech companies situated in Europe.
The assessment from SAXOCON is based on QSAR modeling combined with an expert opinion in order to provide additional supportive evidence on relevance of any positive, negative, conflicting or inconclusive predictions. The reports are delivered in an FDA approved format. The ICH Steering Committee has accepted QSAR modeling for ICH M7 impurity hazard assessment. This involves using two methodologies – one methodology being expert rule-based and the second methodology being statistically based.
The SAXOCON experts have more than 15 years of experience with QASR modeling and have since 2014 performed numerous ICH M7 hazard assessments. All our expert opinions are based on the latest scientific knowledge.
ICH M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.
The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products.
The ICH M7 guideline titled “Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk“ describes how computational toxicology assessment should be performed using QSAR methodologies. These are models that predict the outcome of a bacterial mutagenicity assay to support hazard assessment. In certain cases, this can help avoid having to test impurities or degradants for mutagenicity.