| 引用本文: | 厉高慜,潘伟婧,陈钢,邵泓.中国药典2020年版无菌检查用隔离系统验证和应用指导原则修订概况[J].中国现代应用药学,2021,38(6):641-645. |
| LI Gaomin,PAN Weijing,CHEN Gang,SHAO Hong.Overview of the Revision of Guidelines for Validation and Application of Isolator Systems for Sterility Test in Chinese Pharmacopoeia 2020 Edition[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(6):641-645. |
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| 摘要: |
| 目的 介绍中国药典2020年版对无菌检查用隔离系统验证和应用规范的新要求。方法 分别从生命周期内的风险控制、关键性能特点、设备结构和安装要求、增修订确认项目及初次验证体系、应用注意事项等方面探讨中国药典2020年版中的新要求。结果 修订后的质量标准基于风险建立了更全面的规范。结论 中国药典2020年版可以更好地推进无菌隔离系统在制药实验室的规范应用。 |
| 关键词: 中国药典2020年版 无菌检查用隔离系统 验证 风险管理 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.06.001 |
| 分类号:R953 |
| 基金项目:国家药典委员会药品医疗器械审评审批制度改革专项课题（ZG2016-4-01） |
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| Overview of the Revision of Guidelines for Validation and Application of Isolator Systems for Sterility Test in Chinese Pharmacopoeia 2020 Edition |
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LI Gaomin1, PAN Weijing2, CHEN Gang1, SHAO Hong1
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1.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China;2.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations, Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To introduce the new requirements of the Chinese Pharmacopoeia 2020 Edition about validation and application specifications of isolator systems for sterility test. METHODS The new requirements in Chinese Pharmacopoeia 2020 Edition were discussed from the aspects risk management in life cycle, critical performance characteristics, equipment structure and installation requirements, added/revised qualification items and initial qualification system and precautions in application. RESULTS The revised quality standard established a more comprehensive specification based on risk management. CONCLUSION The Chinese Pharmacopoeia 2020 Edition can better promote the standardized application of aseptic isolator systems in pharmaceutical laboratories. |
| Key words: Chinese Pharmacopoeia 2020 Edition isolator systems for sterility test validation risk management |
