参附注射液风险控制体系构建

Risk control system construction of Shenfu injection

目的:为保证参附注射液质量稳定,控制风险隐患,降低风险损害。方法:在生产、GAP、研发、流通、临床使用、知识产权、紧急事件处理等一系列药品相关环节进行风险筛查、评估,并针对可能存在的风险采取控制和预防。结果:初步构建了参附注射液的风险控制体系。结论:风险控制体系的建立对于中药注射剂品种有着重要意义,今后风险控制的重点在对于风险控制战略的制定、组织架构的完善以及各个部门之间的协作、联动机制等。

Objective： To ensure the stable quality of Shenfu injection, control potential risk and reduce risk damage. Method： To screen and evaluate the risk in the production, GAP, research and development, circulation, clinical application, intellectual property, emergency treatment, control and prevente the potential risks. Result： The risk-control system of Shenfu injection has been constructed initially. Conclusion： It has a great significance for the establishment of traditional Chinese medicive in- jections＇risk-control system. The keys of the risk-control in future are to make strategy, perfect the organization structure and collaborating among various departments.