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Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility.

ABSTRACT: Background: With increasing insecticide resistance in malaria-endemic countries there is an urgent need for safe and effective novel vector control products. To improve the capacity of facilities that test insecticides in sub-Saharan Africa, a programme is supporting seven facilities towards Good Laboratory Practice (GLP) certification, the globally recognized standard for quality management system (QMS) for the conduct of non-clinical and environmental studies. The World Health Organization (WHO) GLP Handbook provides guidance on a stepwise approach to implement a GLP compliant QMS. This study assesses auditor GLP checklists and timings outlined in the WHO GLP Handbook in the real-life context of a Tanzanian insecticide-testing facility, evaluating their implementation in this context. Methods and Principle Findings: We conducted document review and semi-structured interviews with staff at all levels of the test facility to explore factors that influenced progress towards GLP certification. We found that while auditor GLP checklists underemphasised computer systems, they were otherwise broadly applicable. Factors that delayed time to completion of GLP certification included the need for extensive infrastructure improvements, the availability of regional expertise related to GLP, the capacity of national and regional external systems and services to meet GLP compliance requirements, and training development required for Standard Operating Procedure implementation. Conclusion: The standards required for full GLP compliance are rigorous, with an expected completion timeline to implementation of 24 months. This study shows that in low and middle-income countries this timeline may be unrealistic due to challenges related to infrastructure development and lack of regional capacity and expertise. We recommend a comprehensive gap analysis when starting a project, including these areas which are beyond those recommended by the WHO GLP Handbook. These challenges can be successfully overcome and the experience in Tanzania provides key lessons for other facilities seeking GLP certification or the development of similar QMS.

SUBMITTER: Begg S

PROVIDER: S-EPMC7399503 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility.

Begg Sara S Wright Alexandra A Small Graham G Mosha Franklin F Kirby Matthew M Snetselaar Janneke J Aziz Salum S Bharmal Jameel J Dacombe Russell R Bates Imelda I

Gates open research 20200612

<b>Background:</b> With increasing insecticide resistance in malaria-endemic countries there is an urgent need for safe and effective novel vector control products. To improve the capacity of facilities that test insecticides in sub-Saharan Africa, a programme is supporting seven facilities towards Good Laboratory Practice (GLP) certification, the globally recognized standard for quality management system (QMS) for the conduct of non-clinical and environmental studies. The World Health Organizat ...[more]

PMID: 32789289

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Project description:Background: Strengthening capacity for public health research is essential to the generation of high-quality, reliable scientific data. This study focuses on a research capacity strengthening project supporting seven test facilities in Africa conducting studies on mosquito vector control products towards Good Laboratory Practice (GLP) certification. It captures the primary effects of the project on each facility's research capacity, the secondary effects at the individual and institutional level, and the ripple effects that extend beyond the research system. The relationships between effects at different levels are identified and compared to an existing framework for the evaluation of research capacity strengthening initiatives. Methods: To capture the views of individuals engaged in the project at all levels within each facility, a maximum-variation purposive sampling strategy was used. This allowed triangulation between different data sources. Semi-structured interviews were conducted with individuals in three facilities and a combination of email and remote video-call interviews were conducted with individuals at two further facilities. Results: We found that, despite a focus of the GLP certification project at the institutional level, the project had effects also at individual (including enhanced motivation, furtherment of careers) and national/international levels (including development of regional expertise). In addition, we detected ripple effects of the project which extended beyond the research system. Conclusion: This study shows that research capacity strengthening interventions that are focussed on institutional level goals require actions also at individual and national/international levels. The effects of engagement at all three levels can be amplified by collaborative actions at the national/international level. These findings show that research capacity strengthening projects must develop plans that address and evaluate impact at all three levels. Capturing the ripple effects of investment in research capacity strengthening should also be planned for from the beginning of projects to support further engagement of all stakeholders.

Project description:BackgroundLimited health research capacities (HRC) undermine a country's ability to identify and adequately respond to local health needs. Although numerous interventions to strengthen HRC have been conducted in Africa, there is a need to share the lessons learnt by funding organizations, institutes and researchers. The aim of this report is to identify best practices in HRC strengthening by describing a training programme conducted between 2016 and 2017 at the Saint Joseph's Catholic Hospital (SJCH) in Monrovia (Liberia).MethodsA call for trainees was launched at the SJCH, the Liberia Medicines and Health Products Regulatory Authority (LMHRA), the Ministry of Health and Social Welfare, the Mother Pattern College of Health Sciences (MPCHS) and community members. Selected trainees participated in four workshops on Good Clinical Laboratory Practice (GCLP), standard operating procedures (SOP) and scientific communication, as well as in a 5-months eLearning mentoring programme. After the training, a collectively-designed research project on malaria was conducted.ResultsTwenty-one of the 28 trainees (14 from the SJCH, 3 from LMHRA, one from MPCHS, and 10 community representatives) completed the programme satisfactorily. Pre- and post-training questionnaires completed by 9 of the trainees showed a 14% increase in the percentage of correct answers. Trainees participated in a mixed-methods cross-sectional study of Plasmodium falciparum infection among pregnant women at the SJCH. Selected trainees disseminated activities and research outcomes in three international meetings and three scientific publications.ConclusionThis training-through-research programme successfully involved SJCH staff and community members in a practical research exercise on malaria during pregnancy. The challenge is to ensure that the SJCH remains active in research. Harmonization of effectiveness indicators for HRC initiatives would strengthen the case for investing in such efforts.

Project description:BackgroundBangladesh significantly reduced under-5 mortality (U5M) between 2000 and 2015, despite its low economic development and projected high mortality rates in children aged under 5 years. A portion of this success was due to implementation of health systems-delivered evidence-based interventions (EBIs) known to reduce U5M. This study aims to understand how Bangladesh was able to achieve this success between 2000 and 2015. Implementation science studies such as this one provide insights on the implementation process that are not sufficiently documented in existing literature.MethodsBetween 2017 and 2020, we conducted mixed methods implementation research case studies to examine how six countries including Bangladesh outperformed their regional and economic peers in reducing U5M. Using existing data and reports supplemented by key informant interviews, we studied key implementation strategies and associated implementation outcomes for selected EBIs and contextual factors which facilitated or hindered this work. We used facility-based integrated management of childhood illnesses and insecticide treated nets as examples of two EBIs that were implemented successfully and with wide reach across the country to understand the strategies put in place as well as the facilitating and challenging contextual factors.ResultsStrategies which contributed to the successful implementation and wide coverage of the selected EBIs included community engagement, data use, and small-scale testing, important to achieving implementation outcomes such as effectiveness, reach and fidelity, although gaps persisted including in quality of care. Key contextual factors including a strong community-based health system, accountable leadership, and female empowerment facilitated implementation of these EBIs. Challenges included human resources for health, dependence on donor funding and poor service quality in the private sector.ConclusionAs countries work to reduce U5M, they should build strong community health systems, follow global guidance, adapt their implementation using local evidence as well as build sustainability into their programs. Strategies need to leverage facilitating contextual factors while addressing challenging ones.

Dataset Information

Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility.

Publications

Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility.

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