WHO药品预认证微生物实验室质量管理的要求与思考

目的:介绍世界卫生组织(WHO)对药品微生物检测实验室的预认证要求,推动我国药品检测质量管理体系的完善和发展。方法:从预认证实验室应遵循的质量管理原则出发,对照我国实验室ISO/IEC 17025体系要求,分析药品微生物检测实验室在质量管理中的不足。结果:预认证实验室更多地采纳了《药品生产质量管理规范》(GMP)的质量管理理念,而我国药品微生物检测实验室在记录与数据可靠性、基于风险的变更控制和偏差调查等方面的应用与实施还存在较大差距。结论:我国药品微生物检测实验室应学习和借鉴国内外GMP的质量管理经验,不断更新理念,改进质量管理体系,更多地以风险评估方式保障检测数据的可靠性。     

Twenty-five years of the WHO vaccines prequalification programme (1987–2012): Lessons learned and future perspectives

The World Health Organization (WHO) vaccines prequalification programme was established in 1987. It is a service provided to United Nations procurement agencies to ensure that the vaccines supplied through these agencies are consistently safe and effective under conditions of use in national immunization programmes. This review describes the purpose and aims of the programme, its evolution during 25 years of existence, its added value, and its role in the context of the WHO strategy to ensure the global availability of vaccines of assured quality. The rationale for changes introduced during the implementation of the programme is provided. The paper also discusses the resources involved, both human and financial, its performance, strengths and weaknesses and steps taken to maximize its efficiency. This historical perspective is used to inform proposed future changes to the service.     

WHO药品预认证对液相色谱仪性能验证的要求及比较分析

目的提供液相色谱性能验证新方法,为申请WHO药品预认证提供依据。方法介绍了WHO药品预认证对液相色谱性能验证项目和指标的要求,并与我国计量检定规程进行对比,总结了两者的相同点和不同点,并对33台液相色谱仪用上述不同的方法进行检测。结果与结论两个方法对同种设备的检测结果存在不一致情况,WHO药品预认证要求更严格。使用者应根据药品管理需要,选择合适的方法进行验证。     

基于世界卫生组织认证分析我国医药行业国际化的机遇与挑战

目的:对我国医药行业(包括化学原料药及制剂、疫苗、体外诊断试剂)参与世界卫生组织认证(the World Health Organization Prequalification,WHO PQ)情况进行梳理和分析,为我国医药行业国际化发展提供启示和建议。方法:通过文献收集和数据查询,描述性分析了我国化学药品(原料药和制剂)、生物制品(疫苗和体外诊断试剂)WHO PQ的背景、现状和积累的相关经验,并以此讨论我国医药行业国际化进程中面临的机遇与挑战,提出应对途径。结果与结论:对于化学药品而言,中国制剂认证远落后于原料药,应克服其质量准入门槛高、自主创新能力不足等问题。疫苗和体外诊断试剂认证数量少,与企业国际化经验少、资本不集中、缺乏具有国际竞争力产品有关。建议我国医药行业充分吸收印度成功经验,重创新、重人才;发挥中国药检体制优势,由上而下提升药品检验检测能力和质量管理水平;了解WHO采购项目的需求品种,具有优势企业应主动争取WHO技术帮扶;消化本土企业认证经验,因地制宜,加快医药产品国际化进程。     

WHO疫苗预认证总体评估程序概述

目的 介绍世界卫生组织(WHO)疫苗预认证(prequalification,PQ)的程序.方法 依据WHO技术报告《联合国采购疫苗的总体评估程序(WHO/BS/10.2155)》 (Procedure for assessing the acceptability,in principle,of vaccines for purchase by United Nations agencies),对PQ的程序进行介绍,并简述PQ后的监管活动及WHO合作实验室的检定活动等.结果与结论 随着我国药品监管当局通过WHO的疫苗监管体系评估,中国的疫苗生产商可以通过向WHO申请疫苗预认证的方式,使自己生产的某种特定疫苗纳入联合国疫苗采购清单.同时,国家监管机构将在其中起到重要的作用.     

In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme

Blood transfusion remains a routine life‐saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion‐transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high‐quality, safe and well‐performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five‐year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease‐specific IVDs for blood screening laboratories.     

WHO药品预认证中仪器设备管理经验总结

WHO的药品预认证项目是一个由WHO代表联合国来管理和运作的项目,体现一个国家的药品质量控制达到了国际标准,而仪器设备管理是WHO预认证的重点考察对象之一。本文将GPCL与CNAS-CL01：2006对仪器设备管理要求进行对比,介绍了了两者之间的差异,从仪器设备的规章制度、运行管理、性能确认三方面总结WHO药品预认证经验,为申请WHO预认证提供仪器设备管理经验,也为药检机构顺利通过WHO预认证提供保障。     

Community-based interprofessional education for medical, nursing and dental students

This paper presents final results from a 15-month project which evaluated the effectiveness of interprofessional education (IPE) for first and second year medical, nursing and dental students on a community-based placement. The paper initially discusses the current issues within the IPE literature. It goes on to provide background information of this placement. In presenting the project's methodology, the paper describes the use of a 'process-based' approach which tracked the education and social processes connected to IPE. Such an approach has helped overcome some of the problems of using before-and-after designs. Findings from this study are offered in relation to the perspectives of the three participant groups in the placement: students, tutors and service users/carers. The paper goes on to discuss these findings and to draw conclusions for community-based IPE.     

WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants – Key considerations for global use

World Health Organization (WHO) preferred product characteristics describe preferences for product attributes that would help optimize value and use to address global public health needs, with a particular focus on low- and middle-income countries. Having previously published preferred product characteristics for both maternal and paediatric respiratory syncytial virus (RSV) vaccines, WHO recently published preferred product characteristics for monoclonal antibodies to prevent severe RSV disease in infants. This article summarizes the key attributes from the preferred product characteristics and discusses key considerations for future access and use of preventive RSV monoclonal antibodies.     

WHO药品资格预审规划对我国制药企业国际化的启示

目的推广对WHO药品资格预审规划的认识,为我国医药产品走向国际主流市场提出相关策略。方法通过分析WHO药品资格预审规划机构工作程序,从不同角度阐述药品资格预审规划的重要性。结果与结论深入学习国际组织相关法规和技术要求、建立符合国际标准的药品质量管理体系,是有效推进我国制药企业产品参与相关项目国际采购、早日进入国际市场的最佳途径。