Читать книгу Mutagenic Impurities - Группа авторов - Страница 86
2.4.2.1 Question 2.1
ОглавлениеThe relevant section in Section 2 of the guideline states that: “Assessment of the mutagenic potential of impurities as described in this guideline is not intended for the following types of drug substances and drug products: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation products, herbal products, and crude products of animal or plant origin.”
| Question | Answer |
|---|---|
| Are semisynthetic DSs and DPs included in the scope of ICH M7? | Yes, for certain cases. If a semisynthetic DS is manufactured using steps that could introduce mutagenic impurities or degradants (e.g. post‐modification of a fermentation product or late‐stage introduction of a linker), a risk assessment is warranted. The following compounds used in the manufacturing process of semisynthetic DSs and DPs should be considered within the scope of the application of ICH M7:Chemically synthesized intermediates and actual impurities thereinReagents |
This clarification is very important because there were cases where stakeholders considered, for instance, fermentation products, to be excluded from the scope of the ICH M7 guideline, even if they included synthetic steps following the fermentation process. This Q&A makes it clear that any manufacturing step that may introduce a chemical moiety that can be reactive enough to directly react with DNA brings the product within the scope of the application of ICH M7.
