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目的:建立渗透压测定质量控制图。方法:查阅国内相关标准、规定以及文献,结合渗透压测定过程建立质量控制图的实例,提出药品检验实验室建立质量控制图的工作流程。结果:本文制备了渗透压测定质控样,评价了质控样的稳定性和均匀性。在使用此质控样,证明了重复测定结果正态性的基础上,建立了渗透压日常检测结果的质量控制图,并进行了实际应用。结论:建立检验过程质量控制图并对其中的失控状态信号做出反应,是保障药品检验质量可控的重要措施。
Objective: To establish osmotic pressure measurement quality control chart. Methods: Refer to relevant domestic standards, regulations and references, and establish an example of quality control chart based on the measurement of osmotic pressure. The work flow of setting up quality control chart in pharmaceutical testing laboratory is put forward. Results: In this paper, the quality control sample of osmotic pressure was prepared and the stability and uniformity of quality control sample were evaluated. On the basis of using this quality control sample and proving the normality of the repeated measurement results, a quality control chart of the daily test results of the osmotic pressure was established and put into practical application. Conclusion: Establishing the quality control chart of the testing process and responding to the out-of-control status signal is an important measure to control the quality of the drug testing.