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This FAQs section details frequently asked questions about the ICH M7 guidelines. For FAQs on Lhasa products, please refer to the relevant product area.
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What are the ICH M7 guidelines?

The ICH M7 guidelines are for the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals and they provide a practical framework that can be applied to the identification, categorization, qualification and control of mutagenic impurities to limit potential carcinogenic risk. This framework is summarised in Figure 1 of our ICH M7 brochure, with appropriate classes summarised in Table 1.

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