Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved]
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 La...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
F1000 Research Ltd
2020-06-01
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| Series: | Gates Open Research |
| Online Access: | https://gatesopenresearch.org/articles/4-59/v1 |
| _version_ | 1818552038009602048 |
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| author | Sara Begg Alexandra Wright Graham Small Franklin Mosha Matthew Kirby Janneke Snetselaar Salum Aziz Jameel Bharmal Russell Dacombe Imelda Bates |
| author_facet | Sara Begg Alexandra Wright Graham Small Franklin Mosha Matthew Kirby Janneke Snetselaar Salum Aziz Jameel Bharmal Russell Dacombe Imelda Bates |
| author_sort | Sara Begg |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T09:07:52Z |
| format | Article |
| id | doaj.art-27f3615546a14453a32a5ae518794fc5 |
| institution | Directory Open Access Journal |
| issn | 2572-4754 |
| language | English |
| last_indexed | 2024-12-12T09:07:52Z |
| publishDate | 2020-06-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | Gates Open Research |
| spelling | doaj.art-27f3615546a14453a32a5ae518794fc52022-12-22T00:29:36ZengF1000 Research LtdGates Open Research2572-47542020-06-01410.12688/gatesopenres.13133.114320Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved]Sara Begg0Alexandra Wright1Graham Small2Franklin Mosha3Matthew Kirby4Janneke Snetselaar5Salum Aziz6Jameel Bharmal7Russell Dacombe8Imelda Bates9Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UKLondon School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKInnovative Vector Control Consortium (IVCC), Liverpool, L3 5QA, UKKCMUCo-PAMVERC Test Facility, Moshi, 255, TanzaniaLondon School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKLondon School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKKCMUCo-PAMVERC Test Facility, Moshi, 255, TanzaniaLondon School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKBackground: 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.https://gatesopenresearch.org/articles/4-59/v1 |
| spellingShingle | Sara Begg Alexandra Wright Graham Small Franklin Mosha Matthew Kirby Janneke Snetselaar Salum Aziz Jameel Bharmal Russell Dacombe Imelda Bates Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] Gates Open Research |
| title | Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] |
| title_full | Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] |
| title_fullStr | Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] |
| title_full_unstemmed | Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] |
| title_short | Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility [version 1; peer review: 2 approved] |
| title_sort | developing laboratory capacity for good laboratory practice certification lessons from a tanzanian insecticide testing facility version 1 peer review 2 approved |
| url | https://gatesopenresearch.org/articles/4-59/v1 |
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