GFI255 Elemental Impurities in Animal Drug Products Questions and Answers

行业指南：兽药中元素杂质问答汇总

问题列表

Q1:What elements should be evaluated?

应评估哪些元素？

Q2:Is it necessary to test investigational and approved animal drug products for elemental impurities?

是否有必要检测临床试验用兽药和已批准兽药中的元素杂质？

Q3:How should drug product components be evaluated for their potential to introduce elemental impurities into the finished drug products?

要如何评估兽药组份是否可能将元素杂质引入兽药成品呢？

Q4:How should the potential for the container closure and manufacturing equipment to leach elemental impurities into the drug product be addressed?

要如何解决容器密闭器和生产设备可能有元素杂质浸出至兽药中的情况？

Q5:Can a non-specific test, such as the test for heavy metals previously described in USP <231>, be used to test a component, or should instrumental methods, such as those described in USP <233> be used?

非专属性检测如之前 USP<231>里所述的重金属检测方法是否可用于组份检测？还是要使用仪器方法如USP<233>中所述的方法？

Q6:For approved products, should we continue to perform the USP <231> test for heavy metals where it is included in the approved specifications for components of a drug product?

如果已批准的兽药组份质量标准包括有重金属项，对于已批准的兽药，我们是否还要继续按USP<231>进行重金属检测？

Q7:Some USP monographs contain limits for specific elements and, in some cases, a different general chapter, such as USP <211>, Arsenic, or USP <251>, Lead, is referenced. Do these limits apply to veterinary products?

有些USP各论中包括有特定元素的限度，有时会不同于通则如USP<211>“砷”或USP<251>“铅”中的要求。这些限度是否适用于兽药？

Q8:If a certificate of analysis for an excipient or drug substance contains test results for specific elements using an instrumental method per USP <233>, do these tests need to be confirmed as part of vendor qualification?

如果一种辅料或原料药的COA中有采用USP<233>仪器方法的特定元素检测结果，是否需要将这些检测项目作为供应商确认的一部分进行确认？

Q9:When specified elements are known to be present in one or more of the excipients or the drug substance, how should the elemental impurity daily exposure from the drug product be assessed?

如果已知在一种或多种辅料或原料药中会出现特定的元素，要如何评估兽药的元素杂质日暴露值？

Q10:Even in cases where the COA includes results for elemental impurities and a specific risk factor has been identified, often the excipient or drug substance make up a small percentage of the drug product or the COA results demonstrate that the elements are controlled at low levels. Is there a threshold at which we would not be expected to confirm the COA results?

即使COA中包括有元素杂质结果，并且已识别出有某个特定的风险因素，通常辅料或原料药仅是兽药的一小部分，或者COA结果显示元素被控制在极低水平。是否存在一个不要求我们对COA结果进行确认的阈值呢？

Q11:What information should be submitted to the file?

申报资料中要提交哪些信息？

Q12:How should updates to the test methods and limits be reported to the file?

检验方法和限度的更新要如何在申报资料中报告？

Q13:Does this guidance apply to Type A medicated articles?

本指南是否适用于A类治疗用物品？

Q14:What if the drug product contains elements that are for therapeutic benefit?

如果兽药中含有的元素是用于治疗的要怎么办？

Q15:When is it necessary to reassess the risk for the drug product?

什么时候需要对兽药的风险重新评估？

Q16:By what date should we have completed risk assessments for elemental impurities in our products?

我们产品中的元素杂质风险评估要在什么日期完成？

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FDA行业指南：兽药中元素杂质问答

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