全省涉药检测实验室间比对发现的问题及改进措施探讨

Discussion about Problems Identified during Intercomparisons between Drug Control Laboratories and the Countermeasures

目的对2008～2012年全省涉药检测(药品生产企业、医院制剂室、药检机构)实验室间比对发现的问题进行分析汇总,有针对性地提出改进措施和建议,为实验室规范检验操作、改进质量管理,保证检验工作质量提供参考。方法将2008～2012年全省比对结果及参比实验室原始记录中存在的问题进行汇总分析,从提高质量意识、加强人员培训、规范检验检测操作、制定药检基础操作SOP、改进质量管理等方面提出相应的改进措施和建议。结果与结论组织开展全省实验室间比对是帮助辖区各涉药检测实验室验证其质量管理有效性和检测结果可靠性的重要手段,各实验室应积极参加并认真对待。

Objective To put forward corresponding countermeasures and suggestions based on the analysis and discussion about the current problems identified in the intercomparison between drug control laboratories in drug manufacturing enterprises,hospital preparation rooms and drug control institutions across Gansu Province from the year 2008 to 2012 for laboratories to standardize the drug testing operation procedure and improve quality management,in order to ensure the quality of drug testing.Methods The existing problems with the original records from year 2008 to 2012 were analyzed and summarized,and the corresponding improvement measures and recommendations were put forward,such as improving the quality awareness,strengthening the training of personnel,standardizing the operation procedure,developing the standard operating procedure （SOP） of drug testing and improving quality management.Results and Conclusion The inter-laboratory comparison across the whole province is an important means to help the laboratories in difference districts verify the effectiveness of quality management and reliability of drug testing results.The laboratory should actively participate and take it seriously.