药品检验所检品管理问题探讨

On the Sample Management in Institute for Drug Control

目的:为确保检品能够满足检验要求、实验结果具有可追溯性、降低检验风险,探讨科学合理规范地对检品的接收、识别、流转、储存及处置过程各个环节进行严格的控制和有效的管理。方法:通过跟踪检品在药检机构中的流转路径,查找所有环节中可能存在的问题,分析现状并结合检品受理、保存等涉及的法律法规,联系实际,阐述和解决需要注意的问题。结果与结论:通过建立并严格执行完整有效的检品管理制度,消除检品管理过程中可能存在的不安全因素和薄弱环节,提出疑难问题的解决方案,使各项工作更加科学有序地进行。

To establish a complete inspection management system for the institute for drug control, to ensure that the samples can meet that the inspection requirements, to fully demonstrate the quality characteristics of samples, to ensure the traceability of the results and reduce the risk of inspection. The strict and effective management and control of samples’ receiving, identiifcation, transfer, storage, and disposal process were discussed.Methods：By tracking the transfer path in institute for drug control, the current situation was analyzed and all of the possible problems in the process were found out. According to the related laws and regulations on samples acceptance and storage, combined with practical situation, the problems to which attention should be paid were clariifed.Results and Conclusion： Potential unsafe factors and weak links during management process can be eliminated by establishing and strictly implementing the complete and effective samples management. In addition, it is necessary to put forward the solution to the problems, so as to make the work more scientiifc and effective.