2014ICHQ3D元素杂质指南.docVIP

2014-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