Genotoxic Impurities

Rubrik: Praxis

(Treffer aus pharmind, Nr. 06, Seite 971 (2014))

Balbach S

Genotoxic Impurities / CMC Strategies for Risk Evaluation and Minimization in R & D – The Sanofi Approach · Balbach S · Sanofi-Aventis Deutschland GmbH, Frankfurt/Main, Germany
In the early 2000s, regulatory authorities focused on the potential content of genotoxic impurities (GTIs) in study medication intended for clinical trials. Regulatory authorities were in an opinion forming phase and not aligned, since no clear regulatory guidance was at hand from regulation-setting organizations such as EMA, FDA or ICH. In some cases, clinical phase 1 studies were put on hold on the request of 1 ppm limits even for theoretical impurities. Because of the uncertainty created by such expectation, an intense exchange among pharmaceutical companies and regulatory authorities began and companies such as Sanofi proactively developed internal GTI guidelines. In ...