Читать книгу Mutagenic Impurities - Группа авторов - Страница 127

The need to adequately assess the risk posed by MIs, and to limit the level present in API/DP, is clearly established in ICH M7. Within this chapter the authors have looked to define a risk‐based approach to such an assessment, one based on a combination of semiquantitative assessment, allied to analytical results and data from appropriate purging studies. Such an approach should ensure that any actual MI‐related risk is clearly identified and managed.