ICH guideline M7 - mutagens

ICH guideline M7 assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

Q&A Step 2b Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities.

The Q&A document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files.

The scope of the Q&A document follows that of ICH M7. “Applicant” is used throughout the Q&A document and should be interpreted broadly to refer to the marketing authorization holder, the filing applicant, the drug product manufacturer, and/or the drug substance manufacturer.

See: https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-ich-guideline-m7-assessment-control-dna-reactive-mutagenic-impurities_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)