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

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Begg, Sara ORCID: https://orcid.org/0000-0001-9384-9801, Wright, Alexandra, Small, Graham, Mosha, Franklin, Kirby, Matthew, Snetselaar, Janneke, Aziz, Salum, Bharmal, Jameel, Dacombe, Russell ORCID: https://orcid.org/0000-0002-6705-1537 and Bates, Imelda ORCID: https://orcid.org/0000-0002-0862-8199 (2020) 'Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility'. Gates Open Research, Vol 4, Issue 59.

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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.

Item Type: Article
Uncontrolled Keywords: Laboratory, research capacity strengthening, good laboratory practice, insecticide, test facility, quality management system, quality management systems, capacity strengthening
Subjects: QX Parasitology > Insects. Other Parasites > QX 600 Insect control. Tick control
QX Parasitology > Insects. Other Parasites > QX 650 Insect vectors
QY Clinical Pathology > QY 25 Laboratory techniques and procedure
QY Clinical Pathology > QY 4 General works
WA Public Health > Preventive Medicine > WA 240 Disinfection. Disinfestation. Pesticides (including diseases caused by)
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
Faculty: Department: Clinical Sciences & International Health > International Public Health Department
Clinical Sciences & International Health > Clinical Sciences Department
IVCC
Digital Object Identifer (DOI): https://doi.org/10.12688/gatesopenres.13133.1
Depositing User: Tina Bowers
Date Deposited: 25 Jun 2020 11:29
Last Modified: 25 Jun 2020 11:29
URI: https://archive.lstmed.ac.uk/id/eprint/14755

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