目的：减少国家药品标准物质标签及其说明书管理风险的发生及降低风险引发的损失。方法：根据目前国家药品标准物质标签及其说明书管理现状及存在问题，制定一系列措施和方法进行风险控制。结果：规范国家药品标准物质标签及其说明书的录入、审核和排版环节，完善相关质量管理控制体系；建立风险评估和控制机制，提高风险意识、风险知识和工作责任心。结论：通过建立国家药品标准物质标签及其说明书管理的风险评估和控制机制，堵住和减少风险漏洞，降低风险引发的损失，保证国家药品标准物质的质量与安全，为用户提供准确无误的信息。

Objective: To reduce the management risk of the labels and instructions of national pharmaceutical reference standards and reduce the losses caused by the risk. Methods: Causes of the risk were analyzed according to current management situation and existing problems of labels and instructions of the national pharmaceutical reference standards. A series of measures and methods were developed to control the risk. Results: The preparation and production of the labels and instructions of national pharmaceutical reference standards were standardized. A standarized quality control system and risk assessment control system were established. Risk awareness and knowledge of the staff were improved and responsibilities of the staff were enhanced. Moreover, risk management system was updated in a real time manner. Conclusions: Management of labels and instructions of national pharmaceutical reference standards is strengthened through establishing the risk control of the management of labels and instructions of national pharmaceutical reference standards, management risk and the losses caused by the risk are reduced. In this way, quality and safety of national pharmaceutical reference standards is guaranteed and accurate information can be provided for users.