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The four Q&As in Section 1 relate to the Note 1 in the M7 guideline and clarify the meaning of mutagenic and genotoxic potential, as well as the recommendations for evaluation of impurities present below and above 1 mg.

Note 1 in the M7 guideline states as follows (emphasis added on the dubious phrases): “The ICH M7 Guideline recommendations provide a state‐of‐the‐art approach for assessing the potential of impurities to induce point mutations and ensure that such impurities are controlled to safe levels so that below or above the ICH Q3A/B qualification threshold no further qualification for mutagenic potential is required. This includes the initial use of (Q)SAR tools to predict bacterial mutagenicity. In cases where the amount of the impurity exceeds 1 mg daily dose for chronic administration, evaluation of genotoxic potential as recommended in ICH Q3A/B could be considered. In cases where the amount of the impurity is less than 1 mg, no further genotoxicity testing is required regardless of other qualification thresholds.”