文档介绍：学****文档 仅供参考
Translated from / 译自：
Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing 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
学****文档 仅供参考
药品成分
B. Containers/Closures 5
容器/密封
1. Preparation 5
准备
2. Inspection of Container Closure System 5
容器密封系统的检查
VII. ENDOTOXIN CONTROL 5
内***控制
VIII. TIME LIMITATIONS 5
时间限制
IX. VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION 5
无菌加工和灭菌的验证
A. Process Simulations 5
工艺模拟
1. Study Design 5
研究设计
2. Frequency and Number of Runs 5
运行频率和次数
3. Duration of Runs 5
运行时间
4. Size of Runs 5
批量
5. Line Speed 5
运行速度
6. Environmental Conditions 5
环境质量
7. Media 5
培养基
8. Incubation and Examination of Media-Filled Units 5
培养基灌装单位的培养和检查
9. Interpretation of Test Results 5
试验结果解释
B. Filtration Efficacy 5
过滤成效
C. Sterilization of Equipment, Containers, and Closures 5
设备、容器和密封的灭菌
1. Qualification and Validation 5
确认和验证
2. Equipment Controls and Instrument Calibration 5
设备控制和仪器校准
X. LABORATORY CONTROLS 5
实验室控制
A. Environmental Monitoring 5
学****文档 仅供参考
环境监测
1. General Written Program 5
书面程序
2. Establishing Levels and a Trending Program 5
建立监测标准和趋势分析程序
3. Disinfection Efficacy 5
消毒成效
4. Monitoring Methods 5
监测方法
B. Microbiological Media and Identification 5
微生物培养基及微生物的鉴定
C. Prefiltration Bioburden 5
过滤前的生物负荷
D. Alternate Microbiological Test Methods 5
可替代的微生物测试方法
E. Particle Monitoring 5
颗粒监测
XI. STERILITY TESTING 5
无菌试验
A. Microbiological Laboratory Controls 5
微生物实验室控制
B. Sampling and Incubation 5
取样和培养
C. Investigation of Sterility Positives 5
无菌试验阳性结果的调查
XII. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION 5
批生产纪录 工艺控制文件化
APPENDIX 1: ASEPTIC PROCESSING ISOLATORS 5
附录 1: 无菌隔离装置
APPENDIX 2: BLOW-FILL- SEAL TECHNOLOGY 5
附录2： 吹-灌-封技术
APPENDIX 3: PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS 5
附录3