ProtoICH is specially focused on ICH M7 Guideline, aimed to reduce the potential carcinogenic risk of impurities. ICH M7 Guideline proposes the use of computational methods as an alternative for mutagenicity assays. It requires the prediction by means of two computational methodologies: a statistical method (QSAR) and an expert-rule based method. Moreover, it requires the detection of aflatoxins, N-nitrosamines and azoxy compounds (carcinogenicity cohort of concern)