建立医疗器械标准化工作档案有助于提高档案管理工作的整体质量和效率,并推进考核评估工作.文章从医疗器械标准化技术委员会标准化工作档案的管理现状出发,结合档案管理要求和标委会考核评估细则,提出标准化工作档案归纳分类和归档范围的建议,建立医疗器械标准化工作档案的归档指南,为标委会档案管理提供参考.

目的 探讨风险管理在医疗器械标准制修订中的实施方法.方法 基于风险管理的理念及依据医疗器械标准制修订的工作经验,选择危害分析和关键控制点(HACCP)法,从医疗器械标准制修订的立项、起草、验证、征求意见、技术审查、审核批准和发布、实施和评价7个阶段进行分析,梳理出各阶段可能出现的风险点、危害分析与评估、关键控制点及监控措施.结果 与结论风险管理应用于医疗器械标准制修订,有助于提升标准制修订工作质量,控制、消除或减少标准质量风险.

通过对人类辅助生殖技术用医疗器械产品及国内和国际标准化现状进行研究,按照构建标准体系的目标明确、全面成套、层次适当和划分清楚四项基本原则,提出人类辅助生殖技术用医疗器械标准体系的建设思路,共分为基础与通用标准、产品标准、方法标准和其他标准四个方面,并给出建立科学完善的人类辅助生殖技术用医疗器械标准体系的建议,标准体系中各层次及分类中的部分标准需加快研究立项、制定和完善,尤其要重视共性、基础性标准的研究和制定.

基于增材制造技术的医疗器械是一类融合了多学科、多技术的复杂医疗器械,需对其质量进行严格控制,因此有必要制定专用的标准体系来对其进行约束和规范,从而引导产业发展.本文梳理了国际和国内增材制造标准化现状,国际方面主要由ISO/TC 261和ASTM F42从事相关的标准化工作及研究,国内由SAC/TC 562负责机械领域国家标准制修订工作.在医疗领域,医用增材制造技术标准化技术归口单位负责该领域的标准制修订工作.根据增材制造工艺和医疗器械的质控重点,本文从基础标准、数据/软件、设备、材料及工艺/方法5个方面着手,提出标准体系的设计研究思路,为我国医用增材制造技术医疗器械领域标准化工作的科学有序开展提供参考.

为进一步梳理医疗器械标准制修订工作流程,提高标准制修订的工作质量,本文将质量管理中持续改进的理念贯穿于标准制修订工作全环节,将医疗器械标准制修订工作流程中的主要环节与ISO/IEC 17025中的要素一一对应.医疗器械标准的立项、起草验证、征求意见、技术审查、审核批准和发布、实施和评价、复审和废止可对应质量管理体系中的合同评审、内部审核、技术记录、报告结果、记录控制、外部提供的产品和服务、确保结果有效性、纠正措施和管理评审等要素.标准制修订工作流程和质量管理体系运行有相似之处,可以将确保质量管理体系有效运行的方式方法引申到标准制修订工作中,以实现持续改进,提高标准质量的目标.

目的:了解各行业实验室申请测量审核以及中国食品药品检定研究院组织测量审核的情况,为下一阶段的工作奠定基础.方法:对2015～2018年开展的测量审核项目情况进行汇总分析,包括组织项目数量、申请实验室来源和结果满意率等.结果:申请项目数逐年增加,整体通过率在80％以上,电子化管理提高了工作效率.结论:测量审核可以满足实验室认证认可要求,也可以促进组织方体系建设和改进.

目的:应用层次分析法（Analytic Hierarchy Process, AHP）确定国家药品监督管理局药品、化妆品和医疗器械监管重点实验室评价体系各指标权重,为评价提供基础数据支撑。方法:在现有评价指标体系的基础上,依据评分细则中对各指标的重要性评分,构建判断矩阵,运用层次分析法确定一、二级指标权重。结果:基础条件、人才队伍、近五年内科学研究及成果、服务监管能力和社会贡献5个一级指标的权重分别为0.0646、0.0646、0.3579、0.3579和0.1549,模型具有较好的一致性和满意度,一级指标CI为0.014,CR为0.01,二级指标各项CI和CR值均小于0.1。结论:指标权重合理体现了各指标在重点实验室综合能力组成中的相对重要程度,为国家药品监督管理局重点实验室评估提供了量化的评价依据,也为统一专家评分和实验室自评尺度以及机构间的横向比较奠定了基础,具有较高实践应用价值。

Objective: To summarize the intermediate check related problems of instruments and equipment in food and drug testing facilities and to propose a management method of intermediate check of instruments and equipment. Methods: The intermediate check data of four types of common equipment from 2011 to 2015 were analyzed. It was suggested that intermediate check should be managed for the check methods, check organizations and check results based on the analysis of abnormal data. Results: The pass rate of the four types of common equipment from 2011 to 2015 was 89.1％. Intermediate check cycle was adjusted according to the service life of equipment. Conclusion: Intermediate check is an important method to ensure the normal state of instruments and equipment.

"Capacity" and "evaluation" being the key words,literatures in medicine and health field have been searched and the evaluation tools of capacity have been studied according to the steps of the establishment of indicator system,including selection and establishment of the indicators,determination of the weights and data analysis and statistics.The combination of Delphi method and analytic hierarchy process is currently most widely used.The most appropriate and most efficient evaluation tool should be selected based on the object.

本文以《检验检测机构资质认定评审准则》和《检测和校准实验室能力认可准则》及其在微生物和化学检测领域的应用说明(CNAS-CL01、CNAS-CL09、CNAS-CL10)为基础,通过解读条款内容及要求,提炼出药品检验实验室的内审要点,建立了符合药品检验实验室实际运行情况的内审核查方法和体系,为同类实验室内审提供范本.

在药品检验机构实验室建立变更控制体系,采用系统化的变更控制手段,对管理体系发生变化的过程及其可能造成的影响实施有效控制,可以大大提高管理水平,降低质量风险,保证管理体系持续改进的平稳、有效推进.本文总结中国食品药品检定研究院变更控制系统建立的实践经验,结合将实验室检定业务管理信息系统升级项目纳入变更控制体系中进行管理中的典型案例,对药品检验机构实验室变更控制程序的编制要点和变更控制实施的操作方法进行分析阐释,为药检实验室开展变更控制管理提供参考.

The internal audit is important for the management system of laboratory .The article stated how to effectively implement internal audit in drug testing laboratories in terms of the planning , checklist, pattern, problem observation , CAPA of non-compliance and application of results in internal audit .

药品检验机构实验室的质量管理体系中,决定检验检测的正确性和可靠性的要素有很多,包括人员、设施和环境条件、检测方法、仪器设备、样品处置等,人员是其中关键性的因素.本文根据药品检验机构实验室遵循的各项外部认证、认可准则和实验室管理规范中的相关要求,以药品检验机构的业务特点为基础,结合了现代人力资源管理的新理念,对药品检验机构实验室质量管理体系内人员管理的含义、控制要点、基本工作流程和方法进行分析阐述.为保证质量管理体系的有效运行,药品检验机构实验室的人员管理系统中至少应包括确定岗位、配置人员、业务授权、人员培训、监督与考核以及人员管理的定期评审几个控制要点.

目的:评价参加2013年食品药品系统能力验证实验室的检验能力和质量保证能力.方法:按照ISO/IEC17043实施能力验证,采用稳健统计方法并结合专家评议对实验室能力进行评价,采用SPSS软件分析质量保证体系对实验室结果的影响.结果:全国30个省(直辖市、自治区)共166家实验室参加了本次PT项目,累计提交了374个结果,其中满意结果为320个,总体满意率为85.6％.5个项目满意率分别为90.8％、86.7％、78.0％、92.5％和83.5％.药检系统实验室的各项检测能力略高于系统外实验室.所有参加的实验室均具有质量保证体系.结论:参加本次能力验证活动的实验室,多数质量保证水平稳定可靠,具有相应项目的检验能力.获认可项目实验室质量保证能力强,能力验证满意率较高.应进一步加强质量保证能力建设,提升实验室的质量保证能力.

To understand the status of testing skills and quality management in drug testing laboratories. Methods:The items, pass rate and type of participating laboratories of measurement audit were analyzed during 2011-2014. Results:The number of application items was increased year by year, more than half of which focused on the content determination, and the overall pass rate was over 80%. Conclusion:The measurement audit is important for laboratories, which should be further strengthened and standard-ized.

Objective To design,arrange and evaluate the results obtained “from the proficiency testing program NIFDC-PT-004,operated in the 40 laboratories in 30 provinces,”which was intended to assess the proficiency of the laboratories in determination of dissolution of salicylic acid tablets as testing samples and to conduct technical analysis of the outlier results. Methods According to CNAS-GL02 and features of the determination of dissolution of drugs, dissolutions of salicylic acid tablets which were determined by basket method,paddle method and cup method respectively were set as the evaluation index. Statistical analysis was performed on the results obtained from the laboratories in the proficiency testing program, including the total number,mean (outliers excluded),mean±3 SD,minimum,maximum,range and relative standard deviation (RSD).Evaluation criteria were as follows.Results of the determination of dissolution were not satisfactory if the values were outliers judged by Grubbs test method;if the determination value of dissolution-mean>3 SD,the results were unsatisfactory;if the determination value of dissolution-mean≤3 SD,the results were satisfactory. Results The results by basket method from 38 laboratories were satisfactory,which accounted for 95.0% (n=40).By paddle method,results from 40 laboratories were satisfactory,which accounted for 100% (n=40). The results by cup method from 3 3 laboratories were satisfactory, which accounted for 9 7.1% (n=3 5 ). Conclusion The majority of the participant laboratories passed the proficiency test with satisfactory results,which ensured the validity and reproducibility of the results. The laboratories that had unsatisfactory results should carefully review the operation,find the causes and rectify the relevant parts.

Objective To evaluate the results from the 139 laboratories in 30 provinces obtained in the proficiency testing program NIFDC-PT-005, which was intended to assess the proficiency of the laboratories in the determination of Xiaoyanlidan tablet.Technical analysis was also performed for outlier results. Methods Statistic analysis was performed on the results of andrographolide, dehydroandrographolide (quality-indicating compounds of Xiaoyanlidan tablet)and their total amount, including their total number, median, norm IQR (InterQuartile Range ), robust CV (coefficient of variation),minimum,maximum, range and Z-score. Evaluation criteria:if the absolute value of the Z-score is not more than 2 (|Z|≤2),the result is satisfactory;if the |Z| value is between 2 and 3 (2<|Z|<3),the result is questionable;if the |Z| value is not less than 3 (|Z|≥3),the result is unsatisfactory.Results Among 139 laboratories,117 ones (84.2%)obtained satisfactory results of andrographolide,dehydroandrographolide and their total amount.The possible reasons which caused questionable or unsatisfactory results included improper sample preparation (e.g.the coats of the sample were not removed),unsuitable chromatographic condition,use of improper neutral aluminum packing material in purification of target compounds,incorrect calculation formula,etc.Conclusion The maj ority&nbsp;of the participant laboratories passed the proficiency testing program.Most susceptible or unsatisfactory results were caused by technical reasons.

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 drug testing parameters in the accredited organizations in Australia,Japan,Taiwan,UK,America and China 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 necessary to study the accredited experience in foreign countries and explore the expression of the drug testing parameters which fit the characteristics of China’s drug testing laboratories.

Objective To set up quality management criteria for the pharmaceutical quality control laboratories in China,and to guide,standardize the quality management system construction of pharmaceutical laboratories.Methods The international standard ISO/ IEC 17025:2005 " General requirements for the competence of testing and calibration laboratories" was applied as the fundament,and the relevant requirements of the World Health Organization(WHO) " Good practice for pharmaceutical control laboratories"(GPCL) was taken up in combination with the current situation of quality management in domestic drug control institutes.Results and Conclusion The basic framework of quality management criteria for the pharmaceutical quality control laboratories should contain three aspects—quality management,technique management and laboratory safety,including 13 management elements,12 technical elements and one safety element which together form the quality management system of pharmaceutical quality control laboratories.

Objective To investigate the technical level of aflatoxin determination of Provincial Institute for Drug Control and the National Port Institute for Drug Control.To explore and solve the existing problems in aflatoxin determination,so as to promote quality management of laboratories,strengthen and improve the residue detection level.Methods Internationally accepted statistical robustness methods were adopted for the analysis,and "Z-score" was used to evaluate the detection ability.Results Totally 19 laboratories(73.1%) out of 26 enrolled laboratories presented satisfactory results for all experiments.In the Aflatoxin B1 and total aflatoxins Z-score statistics,a total of 7 laboratories appeared 10 times questionable results(or suspicious),unsatisfactory result(or outliers) was observed once from one laboratory.Conclusion The aflatoxin detection level of Provincial Institute for Drug Control and the National port Institute for Drug Control was relative high,but the technical ability of a few laboratories need to be improved,and these laboratories which cannot detect aflatoxins should strengthen of software and hardware construction as soon as possible to fill in the gaps.