PDA TR42-2005 蛋白质工艺验证.pdfVIP

PDA Technical Report No . 42 Process Validation of Protein Manufacturing Pro cess Valida tion of Protein Manufa cturing Task Fo rce Members/Auth ors Chris Bussineau, Ph.D., Chiron Corporation, Co-Chair Rober t Seely, Ph.D., Amgen, Inc., Co-Chair Genevieve Lovitt, G.I. Lovitt Associates, Project Managerffechnical 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 R ebecca A. Devine, Ph.D., Independent Regulat ory Consultant Robert J . F erris, Ph.D., Chiron Corporation K oen de Heyder, GlaxoSmithKline Biologicals Robert W. Juffras, M.S., Wyeth BioPharma Peter L evy, 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., Biogeo Idee Rhona O L eary, Ph.D., Genentech, Inc. Harold van Deinse, Baxter Healthcare Corporation Process Validation of Protein Manufacturing Technical Report No. 42 Supplement Vol. 59 , No. S-4 September/October 2005 © 2005 by PDA PDA Parenteral Drug Association PDA TECHNICAL REPORT NO. 42 PROCESS VALIDATION OF PROTEIN MANUFACTURING Table of Contents 1. INTRODUCTION 1 6.3 Validation Reports 22 1.1 Purpose 1 6.4 Compliance Program 22 1.2 Scope 1 7. APPENDICES 22