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.

Digital Management Systems in Academic Health Sciences Laboratories: A Scoping Review

“…Begg et al [ 35 ] discussed how computer systems are of particular importance in the process of GLP certification in low- and middle-income countries, even though their role is not always emphasized on accreditation systems around the world. This review identified that the knowledge on laboratory management software is mainly originated, as expected, from developed, high-income countries, with advanced information technology industries and significant investment in technology and support for universities and study centers (USA, Germany, Canada, United Kingdom, Switzerland).…”

Ripple effects of research capacity strengthening: a study of the effects of a project to support test facilities in three African countries towards Good Laboratory Practice certification

“…For the purpose of this study, the key dimension of variation was role within the test facility, in recognition that this will have determined both which aspects of the GLP certification process individuals were involved with, and the tasks and duties required of them. Sampling included those who hold key roles within a test facility, as determined by a case-study conducted on the first test facility to achieve GLP certification, KCMUCo-PAMVERC 22 , as well as multiple representatives at each organisational level of the facility. This allowed triangulation between different data sources to determine the trustworthiness of findings.…”

“…Semi-structured interviews were conducted with individual staff members involved in the GLP process in three test facilities: KCMUCo-PAMVERC, NIMR Amani Centre, and CSRS. The interview topic guide 20 was developed based on previous studies of laboratory capacity strengthening 8 , with additional questions derived from findings from a case study of the GLP certification process at PAMVERC-KCMUCo 22 . One overarching question was specifically related to perceived effects of the project.…”

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

“…Semi-structured interviews were conducted to explore the factors influencing the rate of progress towards sustainable GLP certification at their test facility. The interview topic guide was developed based on previous studies of laboratory capacity strengthening [ 10 ], with additional questions derived from findings from a case study of the GLP certification process at KCMUCo-PAMVERC [ 17 ]. Specific questions asked from the topic guide were matched to the roles and responsibilities of the interviewee.…”

“…The KCMUCo-PAMVERC test facility in Moshi, Tanzania was selected as a test case, to establish the feasibility of achieving GLP certification and succeeded in being granted certification in 2017 [ 17 ]. The experience and lessons learnt regarding the process of working towards GLP certification at KCMUCo-PAMVERC were useful subsequently to inform the joint approach by IVCC and the remaining collaborating test facilities.…”