文档介绍：FDA无菌生产指南-中英文对照版
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Guidance for Industry
Sterile Dru46
培养基灌装单位的培养和检查
9. Interpretation of Test Results 48
试验结果解释
B. Filtration Efficacy 50
过滤功效
C. Sterilization of Equipment, Containers, and Closures 53
设备、容器和密封的灭菌
1. Qualification and Validation 54
确认和验证
2. Equipment Controls and Instrument Calibration 56
设备控制和仪器校准
X. LABORATORY CONTROLS 59
实验室控制
A. Environmental Monitoring 61
Contains Nonbinding Recommendations
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环境监测
1. General Written Program 61
书面程序
2. Establishing Levels and a Trending Program 63
建立监测标准和趋势分析程序
3. Disinfection Efficacy 64
消毒功效
4. Monitoring Methods 64
监测方法
B. Microbiological Media and Identification 66
微生物培养基及微生物的鉴定
C. Prefiltration Bioburden 67
过滤前的生物负荷
D. Alternate Microbiological Test Methods 68
可替代的微生物测试方法
E. Particle Monitoring 68
颗粒监测
XI. STERILITY TESTING 69
无菌试验
A. Microbiological Laboratory Controls 71
微生物实验室控制
B. Sampling and Incubation 71
取样和培养
C. Investigation of Sterility Positives 72
无菌试验阳性结果的调查
XII. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION 77
批生产纪录审核：工艺控制文件化
APPENDIX 1: ASEPTIC PROCESSING ISOLATORS 79
附录 1: 无菌隔离装置
APPENDIX 2: BLOW-FILL- SEAL TECHNOLOGY 87
附录2： 吹-灌-封技术
APPENDIX 3: PROCEsSING PRIOR TO FILLING and SEALING OPERATIONS 91
附录3：灌装和密封前的工艺
REFERENCES 94
参考文献
RELEVANT GUIDANCE DOCUMENTS 95
相关指南文件
GLOSSARY 96
术语表
Contains Nonbinding Recommendations
Copyright SCI Version 1
Contains Nonbinding Recommendations
2
Copyright SCI Version 1
Guidance for Industry This guidance was developed by the Office of Compliance in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA).
1本指南由药品评价及研究中心(CDER)与生物制品评价及研究中心(CBER)和法规事务办公室合作编制。
Sterile Drug Products Produced by
Aseptic Processing — Current Good Ma