Читать книгу Mutagenic Impurities - Группа авторов - Страница 36

It was confirmed by the SWP in a Q/A that if MIs associated with a product or substance had been shown to be controlled (i.e. that any MIs associated with the product were controlled to an appropriate safety‐based limit), then it was not necessary to conduct further work to further reduce the levels present. Thus, the driver to have ALARP principles drive further process development of an acceptably safe product was unnecessary.