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8493114 
Journal Article 
ICH guideline M7 on mutagenic impurities in pharmaceuticals 
Snodin, D 
2017 
14 
3 
5-9 
English 
The ICH M7 guideline on “Assessment and Control of DNA-Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” is currently at Step 4.1 It supersedes the previous European Medicines Agency (EMA) and US FDA guidance documents and has been employed by regulators and industry for the past two to three years. This article is intended to provide a brief overview of the main provisions along with some examples of topical issues. © 2017, TOPRA. All rights reserved. 
Active pharmaceutical ingredient (API); Clinical development; Compound-specifi c limits; Drug substance; ICH M7 guideline; Impurity classifi cation; Less-than-lifetime (LTL) limit; Lifetime limit; M7 principles; Mutagenic impurity; Nomenclature; Quality; Structural alerts; Threshold of toxicological concern (TTC)