药包材质量标准中计数抽样检验标准应用探讨  

Research on the Application of Counting Sampling Standards in the Quality Standards on Drug Packaging Materials

作　　者：吴植强 于振凡[2] 方珍文 WU Zhi-qiang;YU Zhen-fan;FANG Zhen-wen(Guangxi Testing Center for Medical Devices;China Standardization Research Institute)

机构地区：[1]广西壮族自治区医疗器械检测中心 [2]中国标准化研究院

出　　处：《中国标准化》2018年第7期111-115,120,共6页China Standardization

摘　　要：针对当前药包材质量标准中注册检验的计数抽样标准及抽样方案存在的不科学问题,对不同计数抽样标准的比较研究和对药包材注册检验的性质进行分析并提出新观点,以使药包材注册检验机构的计数抽样检验更科学可靠并符合法规要求。方法:对目前实行的计数抽样标准的适用性、注册检验机构的角色定位、不同计数抽样标准的设计原理和计数抽样方案的接收概率等方面进行对比分析。结果:药包材注册检验误用计数抽样标准和抽样方案时,不但让检验工作的科学性和经济性受到损害,而且不符合法理的要求,给检验机构带来法律上的风险。结论:药包材注册检验的实质属于质量核查,其抽样方案的正确与否直接关系到检验结果的有效和公正科学,应该在药包材检验工作者中加强宣贯计数抽样标准。Directing at the unscientific problem of counting sampling standards and sampling programs in registration inspection of the quality standards on drug packaging materials, this paper makes comparative analysis of different counting sampling standards and analyzes the nature of registration inspection of drug packaging materials, and puts forward a viewpoint in order to make the sampling inspection of the registration inspection testing institute for drug packaging materials more scientific and reliable and comply with the requirements. Method： This paper makes the comparative analysis of the suitability of current valid sampling standards, the role of registration inspection institutions, the design principles of different sampling standards and probabilities of acceptance of different sampling programs. Result： Misusing counting sampling standards and sampling programs not only affects the scientificity and economy of testing work but also fails to comply with the legal requirements, bringing legal risks to the testing institutions. Conclusion： The registration inspection of drug packaging materials is a kind of quality inspection in essence, the sampling program of which is correct or not is relevant with the validity and impartiality of the test results and therefore the publicity and implementation of counting sampling standard should be strengthened among drug packaging materials testing workers.

关 键 词：药包材 注册检验 计数抽样标准 

分 类 号：F203[经济管理—国民经济]