| 彭茗,范一灵,乐健,杨美成,顾颂青.药品质量控制实验室电子天平期间核查和日常核查管理方法探讨[J].中国药事,2021,35(1):159-163 |
| 药品质量控制实验室电子天平期间核查和日常核查管理方法探讨 |
| On Methods of Implementing Intermediate Checks and Daily Checks for Electronic Balances in Pharmaceutical Quality Control Laboratories |
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| DOI：10.16153/j.1002-7777.2021.02.006 |
| 中文关键词: 电子天平 期间核查 日常核查 |
| 英文关键词: electronic balances intermediate checks daily checks |
| 基金项目: |
| 作者 | 单位 | | 彭茗 | 上海市食品药品检验所,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203 | | 范一灵 | 上海市食品药品检验所,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203 | | 乐健 | 上海市食品药品检验所,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203 | | 杨美成 | 上海市食品药品检验所,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203 | | 顾颂青 | 上海市食品药品检验所,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203 |
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| 中文摘要: |
| 目的：电子天平的期间核查和日常核查均为保证实验室量值溯源有效性的重要组成部分，是药品质量控制实验室保证检测结果准确性的有效手段。研究希望通过实施方法的介绍，为药品质量控制实验室电子天平期间核查和日常核查的展开提供借鉴。方法：通过对电子天平工作原理的认识，梳理使用和核查时的注意事项和相关参数，并根据本实验室的实践经验，介绍了天平期间核查和日常核查的具体实施方法。结果与结论：本文建立的方法可以有效地对电子天平实施期间核查和日常核查，降低因天平不稳定对实验室造成的风险和成本，更有效地维护和保障实验室自身和客户的利益。 |
| 英文摘要: |
| Objective: Intermediate checks and daily checks for electronic balances are important components of the traceability in laboratories, and are effective measures to ensure the accuracy of test results in pharmaceutical quality control laboratories. This study intends to provide references for those laboratories on how to implement intermediate checks and daily checks for electronic balances. Methods: By understanding the working principle of electronic balances, issues needing attention and relevant parameters during the process of checks were sorted out, and the implementing methods for intermediate and daily checks for electronic balances were introduced based on practical experience. Results and Conclusion: The methods for intermediate and daily checks are feasible and effective, which could decrease the risk and cost originating from the lack of stability of balance for the laboratory and more effectively guarantee the interests of both the laboratory and the clients. |
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