| 质量管理在药品研发过程中的应用 |
| 投稿时间：2009-01-04 点此下载全文 |
| 引用本文：刘哲鹏,杨世霆,徐鸽.质量管理在药品研发过程中的应用[J].药学实践杂志,2009,27(4):294~296 |
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| 中文摘要:目的:为药品研究机构建立项目质量管理体系提供参考。方法:运用项目分解的方法,以《药品管理法》、《药品注册管理办法》和《药品生产质量管理规范》(GMP)为依据,针对药品研发的不同阶段提出了相应的管理重点及目标。结果与结论:质量首先是设计出来的,研发阶段的质量管理水平决定了最终产品的质量,规范化的管理、建立并执行良好的研发质量管理体系是优质产品诞生的必要条件。 |
| 中文关键词:药品研发 项目管理 全面质量管理 |
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| Application of the quality management in drug research and development |
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| Abstract:Objective:The study was aimed at the quality management which the department of drug R&D wanted to build.Methods: The method of project breakdown was used.The key-point emphasis and the target in different stage were put forward according to the《Drug Administration Law》,《Provision for Drug Registration》 and 《Good Manufacture Practice》(GMP).Results & Conclusions:The product quality was designed firstly.The quality of the termination product was determined by the level of management in R&D stage.The idea of canonical management and Client-Centered were the guarantee of high quality product. |
| keywords:drug research and development project management total quality management |
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