ICH_Q3D_STEP4 元素杂质指南(中英文).pdf

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 潜在元素杂质的安全评估 ELEMENTAL IMPURITIES 3.1 Principles of the Safety Assessment of 口服、注射和吸入给药中元素杂质安全评估的原 Elemental Impurities for Oral, Parenteral and 则 Inhalation Routes of Administration 3.2 Other Routes of Administration 其它给药途径 3.3 Justification for Elemental Impurity Levels 元素杂质水平高于已建立的PDE 时的论证 Higher than an Established PDE 3.4 Parenteral Products . 注射用药 4. ELEMENT CLASSIFICATION 元素分类 5. RISK ASSESSMENT AND CONTROL OF 元素杂质的风险评估和控制 ELEMENTAL IMPURITIES 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 潜在元素杂质的识别 Impurities 5.4 Recommendations for Elements to be 建议中风险评估中考虑的元素 Considered in the Risk Assessment 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 生物技术衍生产品特殊考虑 Biotechnologically-Derived Products 6. CONTROL OF ELEMENTAL IMPURITIES 元素杂质的控制 7. CONVERTING BETWEEN PDES AND PDE 和关注限度之间的转换 CONCENTRATION LIMITS 8. SPECIATION AND OTHER