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

Gates Open Research

article

Sara Begg¹  Alexandra Wright²  Graham Small³  Franklin Mosha⁴  Matthew Kirby²  Janneke Snetselaar²  Salum Aziz⁴  Jameel Bharmal²  Russell Dacombe¹  Imelda Bates¹ 

[1] Liverpool School of Tropical Medicine;London School of Hygiene & Tropical Medicine;Innovative Vector Control Consortium;KCMUCo-PAMVERC Test Facility

关键词: Laboratory;    research capacity strengthening;    good laboratory practice;    insecticide;    test facility;    quality management system;    quality management systems;    capacity strengthening;   

DOI  :  10.12688/gatesopenres.13133.1

学科分类：电子与电气工程

来源: American Journal Of Pharmtech Research

【 摘 要 】

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.

【 授权许可】

CC BY