国家药品标准物质标签及其说明书管理规范的建立与探讨

On Establishing Management Specifications for National Pharmaceutical Reference Standard Substance Labels and Instructions

目的:建立国家药品标准物质标签及其说明书的管理规范,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。方法:参照药品标签和说明书的管理要求,并结合国家药品标准物质制备与生产现状,建立并探讨国家药品标准物质标签及其说明书的标准操作规范。结果:规范制定国家药品标准物质标签及其说明书生成的工作流程和标准操作规范,应用防伪标识、唯一标识、条形码等信息进行安全管理,确保溯源可控。结论:通过建立国家药品标准物质标签及其说明书管理标准操作规范,加强并完善国家药品标准物质标签及其说明书的管理,保证了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 establish the management regulations for national pharmaceutical standard substance labels and instructions, guarantee the quality and security of national pharmaceutical standard substances, and provide users with accurate information. Methods： According to the management requirements for drug labels and instructions, together with the current preparation and production situation of national pharmaceutical standard substance labels and instructions, the standard regulations for national pharmaceutical standard substance labels and instructions were established and discussed. Results： Work flow and standard operating rules for the production of national pharmaceutical standard substance labels and instructions were specified. Approaches such as anti-counterfeiting mark, unique identification, and two-dimensional code were applied to guarantee safe management and ensure controllable sources. Conclusion： The establishment of the standard operation procedure for the labels and instructions of national pharmaceutical standard substances strengthened and perfected the management of national pharmaceutical standard substance labels and instructions, guaranteed the quality and security of national pharmaceutical standard substance, and provided accurate information for users.