实验室认可中药品参数描述的分析与思考

Analysis and Reflection of the Drug Parameters Described in Laboratory Accreditation

目的规范我国实验室认可药品检验能力的描述。方法分析了澳大利亚、日本、台湾地区、英国、美国以及中国认可机构对药品检验能力的描述情况,并从分类方法、领域代码、检验标准(方法)、标准限度、仪器设备及授权签字人等方面进行了讨论。结果与结论研究并深入学习国外或一些地区认可的经验,探索实施符合我国药品检验实验室特点的药品检验参数表达方式,规范药品检验实验室认可的申请和评审工作。

Objective To understand the description of the drug testing parameters in the accredited organizations both in China and foreign countries, and specify the description of the drug testing parameters in laboratory accreditation. Methods The description of the d accredited organizations in Australia, Japan, Taiwan, UK, America and rug Ch testing parameters in the ina was analyzed, and the classification, field code, specification （method）, the limits of specification, instrument and equipment and authorized signatories were discussed. Results and Conclusion In order to standardize the application and assessment of the drug testing laboratories, it is foreign countries and explore the expression of the drug China＇s drug testing laboratories. necessary to study the accredited experience in testing parameters which fit the characteristics of