浅谈药品检验质量风险管理

Discussion on Quality Risk Management During Drug Testing

目的探讨在药品检验工作中质量风险的确认、分析、评价和审核。方法对影响检验质量的人员技能、仪器设备、样品管理、方法标准、环境控制等5个因素进行阐述。结果与结论实施风险管理可对药品检验工作质量进行有效控制;参加能力验证和比对,对影响因素进行有效控制;开展内部质量审核验证;留样再检验,考察仪器、环境、人员、试剂等条件的控制情况等,能够评价实验室能力,使实验室持续符合质量管理体系要求。

Objective To explore the confirmation, analysis, evaluation and verification of quality risk in drug testing. Methods Five factors which may influence testing quality were elaborated, namely staff professional skills, instruments and equipment, sample management, method standard and environmental control. Results and Conclusion Risk management can effectively control the quality of drug inspection. Participation in the capacity verification and comparison can control the influence factors. Internal quality verification, re-inspection of reserved samples, examination on instruments, reagents, staff and the environment will be used to evaluate the laboratory ability, in order to conform to the requirements of quality management .system in a consistent manner.