ICH Q3D 元素杂质指南 (2).docVIP

5.4 Recommendations for Elements to be Considered in the Risk Assessment?风险评估中要考虑的要素建议 The following table provides recommendations for inclusion of elemental impurities in the risk assessment. This table can be applied to all sources of elemental impurities in the drug product. 以下表格对于风险评估中需要包括的元素杂质做出了建议。该表可以用于药品中所有来源的元素杂质。 Table 5.1: Elements to be Considered in the Risk Assessment 表5.1：?在风险评估中要考虑的元素 Element 元素 Class 分类 If intentionally added (al l routes) 如果有意加入（所有给药途径） If not intentionally added 如果无意加入 Oral 口服 Parenteral 注射 Inhalation 吸入 Cd 镉 1 Yes Yes Yes Yes Pb 铅 1 Yes Yes Yes Yes As 砷 1