OOS调查指南OOS调查指南.doc

OOS调查指南 1（FDA 2006）?? ? 注：英文原版请自行查阅FDA官网，中文系部分下载加自行翻译而成，不当之处请留言。 ? ? Guidance for Industry 行业指南 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production 药品生产中OOS结果的调查 Additional copies are available from: 本文件可自以下途径得到 Office of Training and Communication 培训和交流办公室 Division of Drug Information HFD-240 药品信息分部 Center for Drug Evaluation and Research 药品审评中心 Food and Drug Administration 食品药品管理局 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm ? U.S. Department of Health and Human Services 美国卫生和福利部 Food and Drug Administration 食品药品管理局 Center for Drug Evaluation and Research (CDER) 药品审评中心 October 2006 ? ? ? TABLE OF CONTENTS 目录 ? I. INTRODUCTION 介绍 II. BACKGROUND 背景 III. IDENTIFYING AND ASSESSING OOS TEST RESULTS界定和评价OOS检验结果—? PHASE I: LABORATORY INVESTIGATION第一步：化验室调查 A. Responsibility of the Analyst 化验员职责 B. Responsibilities of the Laboratory Supervisor化验室主管职责 IV. INVESTIGATING OOS TEST RESULTS 对OOS结果的调查—? PHASE II: FULL-SCALE OOS INVESTIGATION 第二步：全面OOS调查 A. Review of Production 生产情况审核 B. Additional Laboratory Testing 附加化验室测试 C. Reporting Testing Results 报告测试结果 V. CONCLUDING THE INVESTIGATION 调查结论 A. Interpretation of Investigation Results 调查结果解释 B. Cautions 注意事项 C. Field Alert Reports 现场警示报告. ? ? GUIDANCE FOR INDUSTRY[1] 行业指南 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production 药物生产中不合格结果的调查 This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 本指南代表FDA对本专题现行的想法。它没有给任何人创造或