(Treffer aus pharmind, Nr. 10, Seite 1474 (2015))
Glowienke S | Stammberger I | Trute A | Veit M
The new ICH M7 Guideline on the assessment and control of mutagenic impurities in pharmaceuticals / Implications on its practical use – Part 1 · Glowienke S, Stammberger I, Trute A, Veit M · 1
Novartis Pharma AG, Basel (Switzerland) und 2
Toxicological Consultancy Services, Hattersheim und 3
F. Hoffmann-La Roche AG, Basel (Switzerland) und 4
i.DRAS GmbH, Planegg
The new ICH M7 Guideline on the assessment and control of mutagenic impurities in pharmaceuticals, coming into force on January 1st, 2016, is intended to consolidate, at a global level, best practice in handling the ‘hot topic genotoxic impurities’, which it has been among regulators and industry for more than 10 years. As a multidisciplinary guideline the ICH M7 comprehensively addresses the impurity assessment by toxicological means as well as those of structure, process and analytical chemistry. Important elements are the derivation of toxicology-based limits and appropriate choice of control measures for (potentially) mutagenic impurities, i. e. DNA-reactive compounds in particular. This ...