| 眼用制剂生产质量管理风险分析及控制 |
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| 引用本文： | 任文霞,翁晓明,刘琛.眼用制剂生产质量管理风险分析及控制[J].中国现代应用药学,2015,32(9):1144-1146. |
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| 作者姓名： | 任文霞 翁晓明 刘琛 |
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| 作者单位： | 浙江医药高等专科学校，浙江 宁波 310053,浙江省药品认证检查中心，杭州 310013,浙江省药品认证检查中心，杭州 310013 |
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| 摘 要： | 随着中国药典2010年版将眼用制剂列入无菌制剂，眼用制剂的生产质量管理被提出了更高的要求。本文对目前眼用制剂生产现状进行分析，探讨眼用制剂生产与质量控制的关键风险点，并提出了一些风险控制策略，为企业提供参考。
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| 关 键 词： | 眼用制剂 药品生产质量管理规范 风险分析 |
| 收稿时间： | 2015/3/19 0:00:00 |
| 修稿时间： | 2015/7/31 0:00:00 |
Risk Analysis and Control Strategies of Production and Quality Management of Ophthalmic Preparations |
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| REN Wenxi,WENG Xiaoming and LIU Chen.Risk Analysis and Control Strategies of Production and Quality Management of Ophthalmic Preparations[J].The Chinese Journal of Modern Applied Pharmacy,2015,32(9):1144-1146. |
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| Authors: | REN Wenxi WENG Xiaoming and LIU Chen |
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| Institution: | Zhejiang Pharmaceutical College, Ningbo 310053, China,Zhejiang Center for Drug Certification&Inspection, Hangzhou 310013, China and Zhejiang Center for Drug Certification&Inspection, Hangzhou 310013, China |
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| Abstract: | Since ophthalmic preparations were defined as sterile preparation by Ch.P 2010, the requirement of production and qulity management of ophthalmic preparations is raised. The production status and the main risk points of the production and quality management of ophthalmic preparations are reviewed and discussed in this article as well as control strategies, aiming to provide some references to manufacturers. |
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| Keywords: | ophthalmic preparations good manufacturing practice risk analysis |
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