PDA No42 Ch 蛋白制造工艺验证 lisa.doc

PAGE  PAGE 41 技术报告42号 蛋白质制造业工艺验证 PDA杂志—制药科学与技术 2005年9/10 增刊 59卷 S-4 技术报告42号 蛋白质制造业工艺验证 蛋白质制造业工艺验证作者 Chris Bussineau, Ph.D., Chiron Corporation, Co-Chair Robert Seely, Ph.D., Amgen, Inc., Co-Chair Genevieve Lovitt, G.I. Lovitt Associates, Project Manager/Technical Editor James Fernandez, Fernandez and Associates, PDA Liaison Greg Blank, Ph.D., Genentech, Inc. E.J. Brandreth, Favrille, Inc. Chris Bussineau, Ph.D., Chiron Corporation Doris Conrad, Consultant, GlaxoSmithKline Biologicals Rebecca A. Devine, Ph.D., Independent Regulatory Consultant Robert J. Ferris, Ph.D., Chiron Corporation Koen de Heyder, GlaxoSmithKline Biologicals Robert W. Juffras, M.S., Wyeth BioPharma Peter Levy, Millennium Pharmaceuticals, Inc. Wolfgang List, Ph.D., Aventis Behring Morten Munk, CMC Biopharmaceuticals A/S Brian C. Neely, Don Hill and Associates, Inc. Stephen Notarnicola, Ph.D., Biogen Idec Rhona O’Leary, Ph.D., Genentech, Inc. Harold van Deinse, Baxter Healthcare Corporation 目 录  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc243462933 1 简介  PAGEREF _Toc243462933 \h 1  HYPERLINK \l _Toc243462934 1.1 目的  PAGEREF _Toc243462934 \h 1  HYPERLINK \l _Toc243462935 1.2 范围  PAGEREF _Toc243462935 \h 1  HYPERLINK \l _Toc243462936 2 定义  PAGEREF _Toc243462936 \h 2  HYPERLINK \l _Toc243462937 3 工艺验证前提条件  PAGEREF _Toc243462937 \h 6  HYPERLINK \l _Toc243462938 3.1 简介  PAGEREF _Toc243462938 \h 6  HYPERLINK \l _Toc243462939 3.2 计划的制定  PAGEREF _Toc243462939 \h 7  HYPERLINK \l _Toc243462940 3.3 工艺的开发  PAGEREF _Toc243462940 \h 8  HYPERLINK \l _Toc243462941 3.3.1 行为的顺序导致正式的工艺验证  PAGEREF _Toc243462941 \h 8  HYPERLINK \l _Toc243462942 3.3.2 原材料  PAGEREF _Toc243462942 \h 10  HYPERLINK \l _Toc243462943 3.3.3 工艺的描述  PAGEREF _Toc243462943 \h 11  HYPERLINK \l _Toc243462944 3.3.4 分析法  PAGEREF _Toc243462944 \h 11  HYPERLINK \l _Toc243462945 3.3.5 风险评估  PAGEREF _Toc243462945 \h 13  HYPERLINK \l _Toc243462946 3.3.6 工艺鉴定  PAGEREF