| 中药注射剂生产企业如何构建风险管理体系 |
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| 引用本文： | 孙秋莹,叶正良,梁毅. 中药注射剂生产企业如何构建风险管理体系[J]. 中国药物警戒, 2012, 9(2): 96-99 |
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| 作者姓名： | 孙秋莹 叶正良 梁毅 |
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| 作者单位： | 1. 中国药科大学,江苏南京,210009
2. 天津天士力之骄药业有限公司,天津,300410 |
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| 基金项目： | 基金项目：重大新药创制项目（2010ZX09602-004）;“重大新药创制”科技重大专项（2012zx09101202） |
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| 摘 要： | 随着中药注射剂(TCMI)药害事件的不断发生,其安全性问题引发了社会的担忧,因此企业实行风险管理势在必行.本文以企业的风险管理经验为例,介绍中药注射剂生产企业应如何构建风险管理体系,如何在以ICH Q9推荐的风险管理模板为指导下,将中药注射剂这一高风险品种的风险降到最低,切实保证药品的质量安全.
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| 关 键 词： | 中药注射剂 风险管理体系 风险评估 风险控制 |
Introduction to TCMI Enterprises on How to Establish Risk Management System |
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| SUN Qiu-ying , YE Zheng-liang , LIANG Yi. Introduction to TCMI Enterprises on How to Establish Risk Management System[J]. Chinese JOurnal of Pharmacovigilance, 2012, 9(2): 96-99 |
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| Authors: | SUN Qiu-ying YE Zheng-liang LIANG Yi |
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| Affiliation: | SUN Qiu-ying YE Zheng-liang LIANG Yi (1China Pharmaceutical University, Jiangsu Nanjing 210009, China; 2Tianjin Tasly Pride Pharmaceutical Co., LTD., Tianjin 300410, China) |
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| Abstract: | With the increasing adverse events of traditional Chinese medicine injection, its safety problem arouses the social＇s concern, therefore it＇s necessary for traditional Chinese medicine injection（TCMI） enterprises to perform quality risk management. This article took the experience of an enterprise as example, introduced to TCMI enterprises how to establish risk management system under the recommendation procedure in ICH Guideline Q9, to achieve the purposes of minimizing risks and ensuring quality and safety of drugs. |
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| Keywords: | traditional Chinese medicine injection risk management system risk assessment risk control |
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