| 引用本文: | 宣泽,江志杰.中国药典2020年版9205药品洁净实验室微生物监测和控制指导原则解读及探讨[J].中国现代应用药学,2023,40(16):2290-2294. |
| XUAN Ze,JIANG Zhijie.Chinese Pharmacopoeia 2020 Edition 9205 Guideline, Microbiological Monitoring and Control in Pharmaceutical Clean Laboratories Interpretation of the Guidelines and Discussion[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(16):2290-2294. |
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| 摘要: |
| 中国药典2020年版9205药品洁净实验室微生物监测和控制指导原则要求对于洁净室相关洁净参数的分析方法、日常测试操作及管理流程有着重要价值。本文通过与中国药典2015年版的分析比较，对比国内外相关标准规定，从检测项目、项目要求细节和具体操作执行等方面，并结合日常检验工作经验，对通则中的关键指标进行重新评估，并提出完善项目或新增项目的建议，为下一版药典指导原则的修订提供参考。 |
| 关键词: 中国药典 美国药典 药品洁净实验室 微生物监测 指导原则 |
| DOI：10.13748/j.cnki.issn1007-7693.20223288 |
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| Chinese Pharmacopoeia 2020 Edition 9205 Guideline, Microbiological Monitoring and Control in Pharmaceutical Clean Laboratories Interpretation of the Guidelines and Discussion |
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XUAN Ze, JIANG Zhijie
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Beijing Institute for Drug Control, Beijing Center for Vaccine Control, NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Beijing 102206, China
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| Abstract: |
| The Chinese Pharmacopoeia 2020 edition 9205 guideline requirements for microbiological monitoring and control of pharmaceutical clean laboratories has an important value for the analysis methods, daily test operations and management processes of cleanroom-related clean parameters. By analyzing the updated comparison with the 2015 edition, comparing the relevant domestic and international standard regulations, from the detection items, details of project requirements and specific operational implementation, and the results of daily inspection work experience, the key indicators in the general rules were re-evaluated and proposed to improve the project or add new items to provide reference for the next edition of the pharmacopoeia guidelines revision. |
| Key words: Chinese Pharmacopeia United States Pharmacopeia pharmaceutical clean laboratories microbiological monitoring guidelines |
