| 陈亚飞,李晓东,刘明理,肖新月.药品标准物质基本特性与规范生产有关质量管理要求[J].中国药事,2017,(2):134-138 |
| 药品标准物质基本特性与规范生产有关质量管理要求 |
| Quality Management Requirements for Pharmaceutical Reference Standards on Essential Characteristics and Production Specifcation |
| 投稿时间：2016-10-24 |
| DOI：10.16153/j.1002-7777.2017.02.004 |
| 中文关键词: 药品标准物质 均匀性 稳定性 准确性 程序合规性 规范生产 |
| 英文关键词: pharmaceutical reference standards homogeneity stability accuracy compliance procedure production standardization |
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| 摘要点击次数: 1009 |
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| 中文摘要: |
| 目的：为规范药品标准物质的研制生产提供参考。方法：结合ISO导则34，根据药品标准物质的基本特性，探讨在全面质量管理新形势下，药品标准物质在均匀性、稳定性、准确性和程序合规性等几方面应遵循的有关要求。结果与讨论：规范和完善药品标准物质生产技术要求和质量管理，是标准物质量值准确、稳定、可靠的保障。 |
| 英文摘要: |
| Objective: To provide references for standardizing the development and production of pharmaceutical reference standards.Methods: Based on the essential characteristics of pharmaceutical reference standards and combining ISO guide 34, this paper discussed the related requirements of pharmaceutical reference standards concerning homogeneity, stability, accuracy and compliance procedure in the current situation for total quality management.Results and Conclusion: It is a necessary guarantee for the accuracy, stability and reliability of assigned values to improve the technical requirements and production quality management for reference standards. |
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