渗透压测定质量控制图制作

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 a quality control chart for osmotic pressure determination. Methods: By searching the standards, the domestic regulations and literatures, the working procedure of quality control chart in drug inspection laboratory were proposed based on the osmotic pressure measurement process. Results: In this paper, the quality control sample for osmotic pressure determination was proposed, and the stability and uniformity of quality control samples were evaluated. Based on the normality of the repeated measurement results using quality control sample, the quality control chart of daily inspection results of osmotic pressure was established, and the practical application was carried out. Conclusion: It is necessary to establish a quality control chart inspection process and make a response to the out-of-control signal, so as to ensure the quality of the drug testing.

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