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1、1 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance ICH 2015 Q3D training module 0 Overview 1 Module 0 Overview of Training Modules ICH Q3D Elemental Impurities International Council for Harmonisation of Technical Requirements for Pharmaceuticals for H
2、uman Use Disclaimer This presentation includes the authors views on Elemental Impurities theory and practice The presentation does not represent official guidance or policy of authorities or industry 2 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance
3、ICH 2015 Q3D training module 0 Overview 2 Legal Notice This presentation 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 presentation is acknowledged at all times
4、 In case of any adaption modification or translation of the presentation reasonable steps must be taken to clearly label demarcate or otherwise identify that changes were made to or based on the original presentation Any impression that the adaption modification or translation of the original presen
5、tation is endorsed or sponsored by the ICH must be avoided The presentation is provided as is without warranty of any kind In no event shall the ICH or the authors of the original presentation be liable for any claim damages or other liability arising from the use of the presentation The above menti
6、oned 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 3 Prepared by the Q3D Implementation Working Group for example only not an official policy gui
7、dance ICH 2015 Q3D training module 0 Overview Principles for developing training materials Intended to provide clarity on key aspects of the guideline in order to facilitate a harmonized interpretation and implementation by industry and regulators in the ICH and non ICH regions Modular approach oOve
8、rview Module 0 oModules 1 7 on key safety and quality topics oModule 8 Three case studies illustrating an approach to presenting the risk assessment oModule 9 Frequently Asked Questions Elaborate on key principles of the guideline Not intended to provide templates for addressing the Q3D recommendati
9、ons Training material does not provide additional guidance beyond Q3D 3 4 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance ICH 2015 Q3D training module 0 Overview Overview of the Guideline Main body references and glossary pages 1 17 Appendix 1 Method
10、 for Establishing Exposure Limits pages 18 20 Appendix 2 Established Permitted daily exposures PDEs for Elemental Impurities by oral parenteral and inhalation routes of administration pages 21 22 Appendix 3 Individual Safety Assessments for 24 elements pages 23 67 Appendix 4 Illustrative Examples pa
11、ges 68 73 4 5 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance ICH 2015 Q3D training module 0 Overview Table of Contents 1 Introduction 2 Scope 3 Safety Assessment of Potential Elemental Impurities 3 1 Principles of the Safety Assessment 3 2 Other Rou
12、tes of Administration 3 3 Justification for Elemental Impurity Levels Higher than an Established PDE 3 4 Parenteral Products 4 Element Classification Module 1 Module 2 Module 4 Large Volume Parenterals 6 Prepared by the Q3D Implementation Working Group for example only not an official policy guidanc
13、e ICH 2015 Q3D training module 0 Overview Table of Contents 5 Risk Assessment and Control of Elemental Impurities 6 Control of Elemental Impurities 7 Converting between PDEs and Concentration Limits 8 Speciation and other Considerations 9 Analytical Procedures 10 Lifecycle Management Appendix 1 Meth
14、od for Establishing Exposure Limits 6 Module 5 Module 6 Module 7 Module 3 Acceptable exposures for elements without a PDE Module 8 Case Studies Module 9 Frequently Asked Questions 7 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance ICH 2015 Q3D trainin
15、g module 0 Overview Training Modules 1 How to Apply Q3D Concepts to Routes of Administration not addressed in Q3D 2 Justification for Elemental Impurity Levels Higher than an Established PDE 3 Application of Q3D concepts to determining safe levels of elements not included in Q3D 4 Large Volume Paren
16、terals 5 Risk Assessment 6 Control of Elemental Impurities 7 Converting between PDEs and Concentrations 8 Case Studies 9 FAQs 7 8 Prepared by the Q3D Implementation Working Group for example only not an official policy guidance ICH 2015 Q3D training module 0 Overview Training Modules 1 How to Apply Q3D Concepts to Routes of Administration not addressed in Q3D 2 Justification for Elemental Impurity Levels Higher than an Established PDE 3 Application of Q3D concepts to determining safe levels of e
