| 董红环,杨玥莹,高芳,梁静,黄清泉.药品检验机构样品管理程序规范化建设研究[J].中国药事,2020,34(2):158-161 |
| 药品检验机构样品管理程序规范化建设研究 |
| Research of Standardization of Sample Management Procedures in Drug Control Institutions |
| 投稿时间：2019-07-29 |
| DOI：10.16153/j.1002-7777.2020.02.004 |
| 中文关键词: 药品检验机构 样品管理程序 |
| 英文关键词: drug control institution sample management procedure |
| 基金项目: |
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| 摘要点击次数: 1351 |
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| 中文摘要: |
| 目的： 为促进药品检验机构样品管理程序的规范化建设，保证检验结果的准确性提供参考。方法： 通过分析样品从进入药品检验机构至销毁整个流转链条中可能影响样品质量的关键因素，结合国内外相关规范性文件，对各环节样品管理提出具体要求。结果与结论： 从受理、传递、留样和销毁各环节对样品的管理提出精细化和标准化控制策略，为药品检验机构制定科学化和规范化的样品管理程序提供参考。 |
| 英文摘要: |
| Objective: To promote the standardization of sample management procedures in drug control institutions and ensure the accuracy of inspection results. Methods: Key factors which could affect the quality of samples during the entire flow chain from receiving to destroying were analyzed. Combined with the relevant normative documents at home and abroad, specific requirements were put forward for each link of sample management. Results and Conclusion: Refined and standardized strategies for sample management of the following aspects, such as acceptance, delivery, retention and destruction were proposed in order to provide references for standardization and normalization of sample management procedures in drug control institutions. |
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