| 王似锦,余萌,王杠杠,马仕洪.非无菌药品中不可接受微生物的控制与风险评估[J].中国药事,2020,34(9):1028-1039 |
| 非无菌药品中不可接受微生物的控制与风险评估 |
| Control and Risk Assessment of Objectionable Microorganisms in Non-sterile Medicines |
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| DOI：10.16153/j.1002-7777.2020.08.006 |
| 中文关键词: 非无菌药品 污染控制 不可接受微生物 风险评估 |
| 英文关键词: non-sterile products contamination control objectionable microorganisms risk assessment |
| 基金项目: |
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| 中文摘要: |
| 目的：就非无菌药品中可能污染的不可接受微生物的相关内容进行综述，为监管部门、药品检验检测机构和药品生产企业提供参考。方法：梳理非无菌药品中不可接受微生物的概念来源、定义及常见种属，比较各国相关的法规、指导原则以及查阅近年的国内外研究文献，简述不可接受微生物的检验策略和风险评估方法。结果与结论：不可接受微生物可通过污染药品影响药品质量威胁患者健康，通过药典的控制菌检查方法可能无法检出，因此应引起重视。各国药典、美国现行药品生产质量管理规范等都要求应使用风险评估的方法控制药品中的不可接受微生物。我国已经有不可接受微生物污染药品的事件发生，应引起监管机构和制药企业的注意，并应尽快建立相关的控制策略、检验方法和风险评估体系。 |
| 英文摘要: |
| Objective: Contents of objectionable microorganisms that may be contaminated in non- sterile products were summarized, which can provide references for regulatory authorities, drug inspection and control institutions and manufacturers. Methods: The concept of objectionable microorganisms was put forward, the common species and genera were listed, and the test strategy and risk assessment method were briefly analyzed according to GMP, Pharmacopoeias, guidelines from China, US and Austrailia. Results and Conclusion: Objectionable microorganisms may affect the quality of drugs and threaten the health of patients, but may not be detected by the test for specified method microorganisms, which should be paid attention to. Contamination control of objectionable microorganisms in pharmaceutical products should be implemented using risk assessment methods according to Pharmacopoeias and Current Good Manufacture Practice of US. There has been objectionable microbial contamination of medical products in China. Regulatory agencies and pharmaceutical enterprises should pay attention to objectionable microorganisms contaminations, and relevant control strategies, test methods and risk assessment system should be established as soon as possible. |
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