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多站点比较影响非洲杀虫剂测试机构向国际质量管理体系认证发展的因素。

Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification.

机构信息

Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom.

London School of Hygiene and Tropical Medicine, Keppel St, Bloomsbury, London, United Kingdom.

出版信息

PLoS One. 2021 Nov 15;16(11):e0259849. doi: 10.1371/journal.pone.0259849. eCollection 2021.

Abstract

BACKGROUND

Insecticidal mosquito vector control products are vital components of malaria control programmes. Test facilities are key in assessing the effectiveness of vector control products against local mosquito populations, in environments where they will be used. Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products. In 2013-4, seven insecticide testing facilities across sub-Saharan Africa, with technical and financial support from Innovative Vector Control Consortium (IVCC), began development and implementation of quality management system compliant with the principles of Good Laboratory Practice (GLP) to improve data quality and reliability.

METHODS AND PRINCIPLE FINDINGS

We conducted semi-structured interviews, emails, and video-call interviews with individuals at five test facilities engaged in the IVCC-supported programme and working towards or having achieved GLP. We used framework analysis to identify and describe factors affeting progress towards GLP. We found that eight factors were instrumental in progress, and that test facilities had varying levels of control over these factors. They had high control over the training programme, project planning, and senior leadership support; medium control over infrastructure development, staff structure, and procurement; and low control over funding the availability and accessibility of relevant expertise. Collaboration with IVCC and other partners was key to overcoming the challenges associated with low and medium control factors.

CONCLUSION

For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors. Project plans should allow additional time for interaction with external agencies to address medium-control factors, and partners with access to expertise and funding should concentrate their efforts on supporting institutions to address low-control factors. In practice, this includes planning for financial sustainability at the outset, and acting to strengthen national and regional training capacity.

摘要

背景

杀虫蚊媒控制产品是疟疾控制规划的重要组成部分。测试设施是评估控制产品对当地蚊媒种群的有效性的关键,这些产品将在其使用的环境中使用。这些测试设施的数据必须具有高质量,才能被监管机构接受,包括世界卫生组织(WHO)病媒控制产品资格预审小组。2013-2014 年,在创新病媒控制联盟(IVCC)的技术和财政支持下,撒哈拉以南非洲的七个杀虫剂测试设施开始制定和实施符合良好实验室规范(GLP)原则的质量管理体系,以提高数据质量和可靠性。

方法和主要发现

我们对参与 IVCC 支持计划并朝着 GLP 方向努力或已经实现 GLP 的五个测试设施的个人进行了半结构访谈、电子邮件和视频电话访谈。我们使用框架分析来确定和描述影响 GLP 进展的因素。我们发现,有八个因素对进展至关重要,而测试设施对这些因素的控制程度不同。它们对培训计划、项目规划和高级领导层支持有高度的控制;对基础设施发展、员工结构和采购有中等程度的控制;对资金的控制程度较低,包括相关专业知识的可用性和可及性。与 IVCC 和其他合作伙伴的合作是克服与中低控制因素相关的挑战的关键。

结论

对于伙伴关系和联盟模式的研究能力建设,测试设施可以利用自己的内部资源来解决确定的高控制因素。项目计划应允许额外的时间与外部机构互动,以解决中控制因素,而有专业知识和资金的合作伙伴应集中精力支持机构解决低控制因素。在实践中,这包括在一开始就规划财务可持续性,并采取行动加强国家和区域培训能力。

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