Читать книгу Mutagenic Impurities - Группа авторов - Страница 28

Pharmaceuticals are in the majority of cases well‐characterized small molecules manufactured by well‐defined chemical synthesis. However, the situation can be quite different in relation to some medicines derived from natural sources. Some of these natural product‐derived medicines, including herbal medicines, can be less well‐characterized materials and are often complex mixtures that may vary batch to batch in terms of components. Of course, the control of impurities in such medicines is also important and by extension one perhaps should consider whether such medicines too might contain potentially MIs [15]. It is, however, practically impossible to apply the same degree of risk management to the manufacture/isolation of a natural product, nor the same degree of process selection and design. How should one approach the management of potential mutagenic risk in such active substances? The EMA guideline [9] provides no specific guidance and therefore EMA published a separate guideline for such products.