| 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. |
| REN Wenxia,WENG Xiaoming,LIU Chen.Risk Analysis and Control Strategies of Production and Quality Management of Ophthalmic Preparations[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(9):1144-1146. |
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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。 |
| 关键词: 眼用制剂 药品生产质量管理规范 风险分析 |
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| Risk Analysis and Control Strategies of Production and Quality Management of Ophthalmic Preparations |
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REN Wenxia1, WENG Xiaoming2, LIU Chen2
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1.Zhejiang Pharmaceutical College, Ningbo 310053, China;2.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. |
| Key words: ophthalmic preparations good manufacturing practice risk analysis |
