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[翻译交流] ICH Q3D 元素杂质指南 (1) ---Hulia翻译

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

GUIDELINE FOR ELEMENTAL IMPURITIES

元素杂质指南

Q3D

Current Step 4 version

dated 16 December 2014

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.


Q3D Document History

Code
History
Date
Q3D
Approval by the Steering Committee under Step 2a.
6 June 2013
Q3D
Approval by the Steering Committee under Step 2b and release for public consultation.
6 June 2013
Q3D
Post sign-off corrigendum in:
l  Table 4.1 W and A1 were removed from the list of included elemental impurities in Class 2B and 3 respectively.
l  Table A2.1 the Class for Ni was changed to read 3 instead of 2
14 June 2013
Q3D
Post sign-off minor editorial corrections including: removal of references to Appendix 5 (pgs i&13); deletion of redundant text (pg4); change of Option 2 to Option 2a(pg10); insertion of text under Safety Limiting Toxicity (pg35); reference to “metals” in text and “metal” in Table A4.7 title with “elementals” and “elements” (pg 73); and deletion of header Table A4.10 (pg75).
26 July 2013
Q3D
Addition of line numbers to facilitate the provision of comments by stakeholders.
30 September 2013
Q3D
Approval by the Steering Committee under Step 4 and recommendation for adoption to the ICH regulatory bodies.
12 November 2014

Current Step 4 Version

Code
History
Date
Q3D
Corrigendum to correct: the modifying factor in the text of the safety assessment for Selenium (changed to 2 instead of 10 consistent with Section 3.1); and two references for consistency in the safety assessments for Barium (deleted reference ) and Vanadium (reviewed reference).
16 December 2014

Legal notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.

The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document.

The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.


GUIDELINE FOR ELEMENTAL IMPURITIES

ICH Harmonised Guideline

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 12 November 2014, this guideline is recommended for adoption to the regulatory parties to ICH.


TABLE OF CONTENTS

目录

1. INTRODUCTION

前言

2. SCOPE

范围

3. SAFETY ASSESSMENT OF POTENTIAL ELEMENTAL IMPURITIES

潜在元素杂质的安全评估

3.1 Principles of the Safety Assessment of Elemental Impurities for Oral, Parenteral and Inhalation Routes of Administration

口服、注射和吸入给药中元素杂质安全评估的原则

3.2 Other Routes of Administration

其它给药途径

3.3 Justification for Elemental Impurity Levels Higher than an Established PDE

元素杂质水平高于已建立的PDE时的论证

3.4 Parenteral Products .

注射用药

4. ELEMENT CLASSIFICATION

元素分类

5. RISK ASSESSMENT AND CONTROL OF ELEMENTAL IMPURITIES

元素杂质的风险评估和控制

5.1 General Principles

通用原则

5.2 Potential Sources of Elemental Impurities

元素杂质的潜在来源

5.3 Identification of Potential Elemental Impurities

潜在元素杂质的识别

5.4 Recommendations for Elements to be Considered in the Risk Assessment

建议中风险评估中考虑的元素

5.5 Evaluation

评估

5.6 Summary of Risk Assessment Process

风险评估过程总结

5.7 Special Considerations for Biotechnologically-Derived Products

生物技术衍生产品特殊考虑

6. CONTROL OF ELEMENTAL IMPURITIES

元素杂质的控制

7. CONVERTING BETWEEN PDES AND CONCENTRATION LIMITS

PDE和关注限度之间的转换

8. SPECIATION AND OTHER CONSIDERATIONS

物种形成和其它考虑

9. ANALYTICAL PROCEDURES

分析方法

10. LIFECYCLE MANAGEMENT

生命周期管理

GLOSSARY

术语

REFERENCES

参考文献

Appendix 1: Method for Establishing Exposure Limits

附录1:建立暴露限度的方法

Appendix 2: Established PDEs for Elemental Impurities

附录2:已建立的元素杂质PDE

Appendix 3: Individual Safety Assessments

附录3:单独安全评估

Appendix 4: Illustrative Examples

附录4:举例说明



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药徒
发表于 2015-1-1 11:32:49 | 显示全部楼层
感谢楼主分享,元旦快乐!
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发表于 2015-1-1 14:17:38 | 显示全部楼层
好高大上的东西
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药生
发表于 2015-1-2 09:43:57 | 显示全部楼层
学习了,巴西木过节还关爱论坛,谢啦!
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发表于 2015-1-10 10:00:14 | 显示全部楼层
谢谢分享,学习了。
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药徒
发表于 2016-11-28 13:24:01 | 显示全部楼层
谢谢分享!
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药徒
发表于 2016-12-1 10:36:06 | 显示全部楼层
非常感谢楼主分享呀
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发表于 2017-4-7 10:26:14 | 显示全部楼层
感谢楼主分享
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发表于 2017-4-8 07:40:42 | 显示全部楼层
谢谢楼主分享

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药徒
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谢谢楼主分享
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药徒
发表于 2017-7-6 14:25:42 | 显示全部楼层
谢谢提供,学习
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发表于 2017-7-20 10:17:36 | 显示全部楼层
谢谢楼主分享
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药徒
发表于 2017-11-6 11:53:51 | 显示全部楼层
谢谢分享~~~~!
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药徒
发表于 2017-11-30 12:41:34 | 显示全部楼层
谢谢分享,挺好用
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药徒
发表于 2018-7-21 14:29:46 | 显示全部楼层
非常感谢上传分享,julia翻译大神,膜拜一下
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药徒
发表于 2018-12-1 15:39:15 | 显示全部楼层
您好,有附录3吗?
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药徒
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药圣
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非常感谢分享
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