FDA无菌加工生产的无菌药品指南中英文对照版

人员 B. Laboratory Personnel ..................................................................................................................25
实验室人员 C. Monitoring Program ....................................................................................................................25
监控程序
VI. COMPONENTS AND CONTAINER/CLOSURES .................................................... 27
药品成分和容器 /密封 A. Components..................................................................................................................................27
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
http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training and Manufacturers Assistance, HFM-40
U.S. Department 来自百度文库f 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
Copyright SCI Version 1
Contains Nonbinding Recommendations
TABLE OF CONTENTS
I.
INTRODUCTION............................................................................................................. 1
Office of Regulatory Affairs (ORA) September 2004
Pharmaceutical CGMPs
Copyright SCI Version 1
Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing— Current Good Manufacturing Practice
容器 /密封 1. Preparation ....................................................................................................................................30
设计
V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING
........................ 20
人员的培训，资格认定和监控 A. Personnel.......................................................................................................................................21
III. SCOPE ............................................................................................................................... 4
适用范围
IV. BUILDINGS AND FACILITIES .................................................................................... 6
Copyright SCI Version 1
Contains Nonbinding Recommendations
药品成分 B. Containers/Closures.....................................................................................................................30
.................. 37
无菌加工和灭菌的验证 A. Process Simulations ....................................................................................................................3. 7
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）
Center for Biologics Evaluation and Research Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.
法规架构 B. Technical Framework .................................................................................................................... 3
技术架构
膜过滤 2. High-Efficiency Particulate Air (HEPA) ....................................................................................... 14
高效颗粒空气过滤器 (HEPA) E. Design............................................................................................................................................16
内毒素控制
VIII. TIME LIMITATIONS ................................................................................................... 36
时间限制
IX. VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION
辅助洁净区域 C. Clean Area Separation ................................................................................................................ 11
净化区的隔离 D. Air Filtration ................................................................................................................................ 12
简介
II. BACKGROUND ............................................................................................................... 2
背景 A. Regulatory Framework ................................................................................................................. 2
(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)
空气过滤 1. Membrane ......................................................................................................................................13
厂房和建筑 A. Critical Area –Class 100 (ISO 5) ................................................................................................. 8
关键区域 –100 级 (ISO 5) B. Supporting Clean Areas ..............................................................................................................11
准备 2. Inspection of Container Closure System ........................................................................................32
容器密封系统的检查 VII. ENDOTOXIN CONTROL ............................................................................................. 34