Glowienke, Susanne (2016) The new ICH M7 Guideline on the assessment and control of mutagenic impurities in pharmaceuticals – Implications on its practical use. PharmInd.

Abstract

The new ICH M7 Guideline "ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK“ provides guidance on safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.

The paper describes the basic requirements of the guideline from a safety and an analytical view point.

Item Type:	Article
Date Deposited:	28 Apr 2016 23:45
Last Modified:	28 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/26539