| 引用本文: | 骆益,曾苏.制药过程偏差调查系统性工具及应用评价浅析[J].中国现代应用药学,2024,41(20):15-23. |
| LUO YI,ZENG Su.Analysis of systematic tools and application evaluation for pharmaceutical process deviation investigation LUO Yi1,2, ZENG Su1,*(1.College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China；2.Pfizer Biologics(Hangzhou) Company Limited, Hangzhou 310020, China)[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(20):15-23. |
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| 摘要: |
| 摘要：目的 探讨制药企业在偏差调查工具、偏差调查系统有效性评价模型的应用。方法 通过文献研究，综述偏差调查系统研究现状，结合工作实践，阐释如何应用偏差调查工具、偏差调查系统有效性评价模型来帮助企业构建和优化偏差调查系统。结果 制药企业获得偏差调查系统构建和优化的思路。结论 定期应用偏差调查系统有效性评价工具，识别改进项，构建有效的偏差调查系统，进一步保证药品的安全性、有效性和质量可控性。 |
| 关键词: 药品质量 偏差调查工具 人为差错 有效性评价 |
| DOI：10.13748/j.cnki.issn1007-7693.20240153 |
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| Analysis of systematic tools and application evaluation for pharmaceutical process deviation investigation LUO Yi1,2, ZENG Su1,*(1.College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China；2.Pfizer Biologics(Hangzhou) Company Limited, Hangzhou 310020, China) |
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LUO YI,ZENG Su
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Zhejiang University
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| Abstract: |
| OBJECTIVE To explore the application of investigation tools and the effectiveness evaluation methods in the pharmaceutical enterprises. METHODS Through literature research, to show the current achievement of investigation system. And combined with practice, explain how to apply the investigation tools and the effectiveness evaluation methods to help enterprises construct and enhance investigation system. RESULTS Enterprises gain insights into the construction and enhancement of investigation systems. CONCLUSION Regularly apply investigation effectiveness evaluation method to identify enhancement opportunities, construct an effective investigation system and further ensure the safety, effectiveness and quality controllability of the drug. |
| Key words: drug quality deviation investigation tool human error evaluation system |
