A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies

Regul Toxicol Pharmacol. 2017 Nov:90:22-28. doi: 10.1016/j.yrtph.2017.08.008. Epub 2017 Aug 16.

Abstract

The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions.

Keywords: Expert review; ICH M7; Mirabilis; Mutagenic impurity; Purge; Purge Ratio.

MeSH terms

  • Computer Simulation
  • Drug Contamination / prevention & control*
  • Humans
  • Mutagenicity Tests / methods
  • Mutagenicity Tests / standards*
  • Mutagens / toxicity*
  • Pharmaceutical Preparations / chemical synthesis
  • Pharmaceutical Preparations / standards*
  • Practice Guidelines as Topic
  • Quality Control
  • Quantitative Structure-Activity Relationship
  • Risk Assessment
  • Technology, Pharmaceutical / standards*

Substances

  • Mutagens
  • Pharmaceutical Preparations