FDA工艺验证总则指南.doc

GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION 工艺验证总则指南 MAY, 1987 1987年5月 Prepared by: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health Food and Drug Administration 起草：药物审评与研究中心，生物学评估与研究中心 器械及放射学卫生中心 食品药品管理局 Maintained by: Division of Manufacturing and Product Quality (HFD-320) Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration 保存：制造与产品质量（HFD-320）部门 法规管理办公室 药物审评与研究中心 食品药品管理局 5600 Fishers Lane Rockville, Maryland 20857 Reprinted February, 1993 by The Division of Field Investigations Office of Regional Operations Office of Regulatory Affairs U.S.Food and Drug Administration 马里兰州，罗克维尔，渔夫巷5600号，邮编：20857 美国食品药品管理局 现场调查部门 区域业务办公室 日常事务办公室 1993年2月再版 Center for Devices and Radiological Health Food and Drug Administration Note: This printed form of the Guideline was prepared by Dr. Arthur Shaw, Food and Drug Administration, for a Course offered by the Center for Professional Advancement in March of 1994. There have been no changes in the text from the original printed version of the Guideline.However the text has been reformatted to reduce the number of pages. The Table of Contents reflects the new pagination. The old pagination is noted in the Guideline. 备注：该指南印刷版本由专业促进中心于1994年3月提供方案，由食品药品管理局阿瑟·肖博士起草完成。该指南在内容上没有对原版做任何变动，只是对文本进行重新排版，减少了文本的页数。这从目录上可以反映出来，本文对原印刷版本的页码进行了加注。 TABLE OF CONTENTS 目录 PURPOSE 目标 II. SCOPE 范围 III. INTRODUCTION 介绍 IV. GENERAL CONCEPTS 基本概念 V. CGMP REGULATIONS FOR FINISHED PHARMACEUTICALS 成品药CGMP章程 GMP REGULATION FOR MEDICAL DEVICES 医疗器材GMP章程 PRELIMINARY CONSIDERATIONS 初步注意事项 VIII. ELEMENTS OF PROCESS VALIDATION 工艺验证要素 A. Prospective Validation A.前验证 1. Equipment and Process 设备与工艺 a. Equipment : Installation Qualification a.设备：安装确认 b. Process: Performance Qualification b.工艺过程：性能确认 c. Product: Performance Qualification c.产品：性能确认 2. System to Assure Timely Revalidation 确保适时再