GMP: Final ICH M7 Guideline on Genotoxic Impurities published

On on 15 July 2014, the ICH issued the guideline M7 \"Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk\" as Step 4 document. In the last step of the ICH process (Step 5) this guideline now has to be implemented in the national regulations in the three ICH regions Europe, United States and Japan.