ICH Q3D 元素杂质指南 (2) ----Julia翻译

巴西木

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	Yes	Yes	Yes	Yes
Hg	汞	1	Yes	Yes	Yes	Yes
Co	钴	2A	Yes	Yes	Yes	Yes
V	钒	2A	Yes	Yes	Yes	Yes
Ni	镍	2A	Yes	Yes	Yes	Yes
Tl	铊	2B	Yes	No	No	No
Au	金	2B	Yes	No	No	No
Pd	钯	2B	Yes	No	No	No
Ir	铱	2B	Yes	No	No	No
Os	锇	2B	Yes	No	No	No
Rh	铑	2B	Yes	No	No	No
Ru	铷	2B	Yes	No	No	No
Se	硒	2B	Yes	No	No	No
Ag	银	2B	Yes	No	No	No
Pt	铂	2B	Yes	No	No	No
Li	锂	3	Yes	No	Yes	Yes
Sb	锑	3	Yes	No	Yes	Yes
Ba	钡	3	Yes	No	No	Yes
Mo	钼	3	Yes	No	No	Yes
Cu	铜	3	Yes	No	Yes	Yes
Sn	锡	3	Yes	No	No	Yes
Cr	铬	3	Yes	No	No	Yes

5.5 Evaluation 评估

As the potential elemental impurity identification process is concluded, there are two possible outcomes:

在对潜在元素杂质进行识别后，可能会有两种结论：

1)    The risk assessment process does not identify any potential elemental impurities. The conclusion of the risk assessment and supporting information and data should be documented.

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)    The risk assessment process identifies one or more potential elemental impurities. For any elemental impurities identified in the process, the risk assessment should consider if there are multiple sources of the identified elemental impurity or impurities and document the conclusion of the assessment and supporting information.

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。

The applicant’s risk assessment can be facilitated with information about the potential elemental impurities provided by suppliers of drug substances, excipients, container closure systems, and manufacturing equipment. The data that support this risk assessment can come from a number of sources that include, but are not limited to:

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：

-     Prior knowledge;

-     之前的知识

-     Published literature;

-     出版的文献

-     Data generated from similar processes;

-     从类似工艺中产生的数据

-     Supplier information or data;

-     供应商的信息或数据

-     Testing of the components of the drug product;

-     药品组分检测

-     Testing of the drug product.

-     药品检测

During the risk assessment, a number of factors that can influence the level of the potential impurity in the drug product and should also have been considered in the risk assessment. These include but are not limited to:

在风险评估中，很多因素会对药品中潜在杂质的水平造成影响，因此也需要在风险评估中进行考虑。这包括但不仅限于：

-     Efficiency of removal of elemental impurities during further processing;

-     进一步加工中除去元素杂质的有效性

-     Natural abundance of elements (especially important for the categories of elements which are not intentionally added);

-     自然富含的元素（特别重要的是没有添加单身的杂质类别）

-     Prior knowledge of elemental impurity concentration ranges from specific sources;

-     特定来源的元素杂质浓度已有知识

-     The composition of the drug product.

-     药品组分

5.6 Summary of Risk Assessment Process 风险评估过程的总结

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