ICH M7(R2) Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit potential carcinogenic risk
Title:
ICH M7(R2) Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit potential carcinogenic risk
Short Title:
M7(R2)
Origin/Publisher:
Document Type:
ICH Guideline
Content:
This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities