ICH Q3D 元素杂质指南 (2)

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1、5.4RecommendationsforElementstobeConsideredintheRiskAssessment 风险评估中要考虑的要素建议Thefollowingtableprovidesrecommendationsforinclusionofelementalimpuritiesintheriskassessment.Thistablecanbeappliedtoallsourcesofelementalimpuritiesinthedrugproduct.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

2、所有来源的元素杂质。Table5.1:ElementstobeConsideredintheRiskAssessment表5.1： 在风险评估中要考虑的元素Element元素Class分类Ifintentionallyadded(allroutes)如果有意加入（所有给药途径）Ifnotintentionallyadded如果无意加入Oral口服Parenteral注射Inhalation吸入Cd镉1YesYesYesYesPb铅1YesYesYesYesAs砷1YesYesYesYesHg汞1YesYesYesYesCo钴2AYesYesYe

3、sYesV钒2AYesYesYesYesNi镍2AYesYesYesYesTl铊2BYesNoNoNoAu金2BYesNoNoNoPd钯2BYesNoNoNoIr铱2BYesNoNoNoOs锇2BYesNoNoNoRh铑2BYesNoNoNoRu铷2BYesNoNoNoSe硒2BYesNoNoNoAg银2BYesNoNoNoPt铂2BYesNoNoNoLi锂3YesNoYesYesSb锑3YesNoYesYesBa钡3YesNoNoYesMo钼3YesNoNoYesCu铜3YesNoYesYesSn锡3YesNoNoYesCr铬3YesNoNo

4、Yes 5.5Evaluation 评估Asthepotentialelementalimpurityidentificationprocessisconcluded,therearetwopossibleoutcomes:在对潜在元素杂质进行识别后，可能会有两种结论：1)    Theriskassessmentprocessdoesnotidentifyanypotentialelementalimpurities.Theconclusionoftheriskassessmentandsupportinginformationanddata

5、shouldbedocumented.1)    风险评估未能识别出任何潜在元素杂质。风险评估的结论和支持性资料和数据要进行记录。2)    Theriskassessmentprocessidentifiesoneormorepotentialelementalimpurities.Foranyelementalimpuritiesidentifiedintheprocess,theriskassessmentshouldconsideriftherearemultiplesourcesoftheidentifiedelementalimpu

6、rityorimpuritiesanddocumenttheconclusionoftheassessmentandsupportinginformation.2)    风险评估识别出了一个或多个潜在元素杂质。对所有识别出的元素杂质，如果该元素杂质有多个来源，要考虑进行风险评估。并记录评估的结论和支持性资料。Theapplicant’sriskassessmentcanbefacilitatedwithinformationaboutthepotentialelementalimpuritiesprovidedbysuppliersofdru

7、gsubstances,excipients,containerclosuresystems,andmanufacturingequipment.Thedatathatsupportthisriskassessmentcancomefromanumberofsourcesthatinclude,butarenotlimitedto:申报人的风险评估可以利用原料药、辅料、容器密闭系统和生产设备供应商提供的关于潜在元素杂质的信息。支持风险评估的数据可以来自于许多来源，包括但不仅限于：-     Priorknowledge;-     之前的知识-

8、     Publishedliterature;-     出版的文献-     Datageneratedfromsimilarprocesses