疫苗研制项目中仪器设备的期间核查  

Discussion on good performance of periodical check in food and drug testing institutions

作　　者：马颖[1] 曾明[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国医学装备》2012年第11期4-6,共3页China Medical Equipment

基　　金：十一五"863国家重大专项课题(2006AA02A236)"病原细菌保护性抗原筛选及疫苗研制

摘　　要：目的:疫苗研制项目中应重视科研用仪器设备的期间核查工作,以保持设备检定和(或)校准状态的可信度。尽量降低由于设备量值不准确而引起的检测数据失准的风险。方法:阐述仪器设备期间核查的目的、意义、方法、结果判定、期间核查仪器的正确选择和计划的制订、实施等,并对核查实例情况进行汇总、分析。结果:建立起规范的检验核查标准与方法,确保对仪器设备、计量器具和装置等提供的检测结果准确可靠。结论:严格按照规定的程序和时间完成期间核查计划,以保持仪器设备的准确性和可信性,为疫苗研制项目中出具严谨、科学和公正的检测数据提供硬件保障。Objective：Food and drug testing institutions should pay close attention to the instrument and equipment during check in order to maintain the the instrument and equipment testing /calibration status of credibility and minimize the risk of an inaccurate food and drug Testing report caused by inaccurate equipment measurement.Methods：Instrument and equipment should be elaborated during the check of the purpose,significance,methods and results to determine the correct choice of the instrument and plans to develop and implement to verify the instance to conduct aggregated analysis.Results：We must establish standard specifications and methods for check to provide accurate and reliable results of testing.Conclusion：The check plan should be completed in strict accordance with the procedures and time to maintain the accuracy and credibility of the instrument and provide hardware protection for the food and drug testing institutions to issue strict,scientific and unbiased inspection reports.

关 键 词：期间核查 仪器设备 量值溯源 标准物质 

分 类 号：TH77[机械工程—仪器科学与技术]