国家药品标准物质一级直供的实施要点研究

标准物质是药品检定的重要物质基础,法定供应国家药品标准物质是中国食品药品检定研究院(简称中检院)的主要职能之一.2019年,中检院对标准物质的供应模式实施了改革,改变两级供应而全面实施一级直供,面对激增的工作量与严格的质量控制要求,中检院通过调整部分工序环节、建成分发可追溯制度、建立9步包装工序、约束运输时效等措施,基...

Key points on direct distribution for national drug reference standards

Reference standards are important material basis for drug control,meanwhile legal distribution of the national drug reference standards is one of the basic functions of NIFDC.A reform of distribution model for reference standard has been carried out by NIFDC in 2019,which changed the past two-level distribution and fully implemented direct distribution to users.Some key points are applied by NIFDC who faces the increasing workload and strict quality control requirements,including adjusting process links,establishing distribution traceability system,founding 9 steps of packaging procedure,building limitation of transportation and so on.As a result,smooth transition to direct distribution was realized.In order to provide guidance to improve the efficiency of reference standard management,this article summarizes the methods of efficiency improvement,analyzes the strategies of quality control,and combs the process nodes.In addition to the above points,some conclusions are made,such as the foundation to direct distribution was providing resources effectively,the powerful tool was intelligent external distribution platform,the significant guarantee was training and guiding users to order correctly.