Eudralex Volume 3 ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Title:
Eudralex Volume 3 ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Short Title:
EMA/CHMP/ICH/83812/2013

https://www.gmp-compliance.org/files/guidemgr/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf

Origin/Publisher:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
Guideline
Content:
This Guideline describes a general framework and practical approaches on how to deal with genotoxic impurities in new drug substances and drug products.

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