FDA无菌生产指南 中英文对照版.doc

Translated from / 译自： Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 行业指南 无菌加工生产的无菌药品 —现行的生产质量管理规范(cGMP） U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA) September 2004 Pharmaceutical CGMPs  Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 /cber/guidelines.htm. (Tel) Voice Information System at 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory affairs (ORA) September 2004 Pharmaceutical CGMPs TABLE OF CONTENTS I. Introduction 1 简介 II. Background 2 背景 A. Regulatory Framework 3 法规架构 B. Technical Framework 3 技术架构 III. Scope 4 适用范围 IV. BUILDINGS AND FACILITIES 5 厂房和建筑 A. Critical Area – Class 100 (ISO 5) 5 关键区域– 100级 (ISO 5) B. Supporting Clean Areas 5 辅助洁净区域 C. Clean Area Separation 5 净化区的隔离 D. Air Filtration 5 空气过滤 1. Membrane 5 膜过滤 2. High-Efficiency Particulate Air (HEPA) 5 高效颗粒空气过滤器(HEPA) E. Design 5 设计 V. PERSONNEL TRAINING, QUALIFICATION, MONITORING 5 人员的培训，资格认定和监控 A. Personnel 5 人员 B. Laboratory Personnel 5 实验室人员 C. Monitoring Program 5 监控程序 VI. COMPONENTS AND CONTAINER/CLOSURES 5 药品成分和容器/密封 A. Components 5 药品成分 B. C