2014-12-16 ICH Q3D 元素杂质指南.docVIP

ICH Q3D 元素杂质指南 Current?Step 4?version dated 16 December 2014 该指南目的是提供一份全球方针来定性和定量限制药品和药品组份中金属杂质。已有ICH Q3A指南将杂质分类为有机杂质、无机杂质和残留溶剂。Q3A和Q3B指南有效地说明了对有机杂质的要求，Q3C阐明了残留溶剂的要求。新指南Q3D将对金属提供类似的说明，金属包括在ICH无机杂质中。 ? 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  GUIDELINE FOR ELEMENTAL IMPURITIES 元素杂质指南 Q3D 1. INTRODUCTION?介绍 药品中的元素杂质可能会有几个来源，它们可能是有意加入合成反应的催化剂的残留，也可能是作为杂质出现（例如，通过与工艺设备或容器/密闭系统