PDA TR38（中文）层析系统批准后的变更_ChromPAC_2006.pdfVIP

TECHNICAL REPORT # 38: 技术报告# 38 Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing,and Controls Documentation 生产层析系统批准后的变更：化学，生产和控制文件 Table of Contents 目录 1. INTRODUCTION 简介2 2. BACKGROUND/SCOPE 背景/范围2 3. PURPOSEOFTECHNICAL REPORT 技术报告的目的2 4. GENERAL CONSIDERATIONS总则3 5. ASSESSMENT OFCHANGE 变更评估4 5.1 Comparability of Impurity Profiles 杂质分布图的相似性5 5.2 Product- and Process-Related Substances 产品和工艺相关物质6 5.3 Comparability of Physical Properties 物理属性的相似性7 6. TYPES OFCHANGES 变更类型7 6.1 Documentation 文件7 6.2 Change Tables 变更图表8 6.2.1Mobile Phase 流动分析9 6.2.2 Stationary Phase 固定相 10 6.2.3 Chromatographic Conditions 层析条件11 6.2.4 Equipment 设备13 6.2.5 Changes in Column Size (Scale Up/Scale Down) 柱尺寸变更 （按尺寸增 加减少）/ 15 6.2.6 Addition/Subtractionof Column(s) 柱的增加减少/ 17 6.2.7 Site Changes 位置变更18 6.2.8 Multiple, Related Changes 多种相关变更21 Appendix A: Factors to Considerwhen Changing Chromatographic Systems 改变层析 系统需考虑的因素 21 Appendix B: Drug Substance CharacterizationTests 药品特征测试22 Appendix C:Glossary 术语22 1. Introduction 简介 This technical report is based on an original PDA commentary that was submitted on October 2004 to Docket number 03N-0059 as a proposed guidance for post-approval change for the Food and Drug Administrations (FDAs) future consideration under the st Pharmaceutical cGMPs for the 21 Century: A Risk Based Approach Initiative. The technical report addresses post-approval changes to drug substance manufacturing processes for chromatography systems and outlines in change tables the recommended test documentation in support of the change. The technical report has omitted the specific reportin