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

Sara Begg1, Alexandra Wright2, Graham Small3

  • 1Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.

Gates Open Research
|August 14, 2020
PubMed
Summary

Achieving Good Laboratory Practice (GLP) certification for insecticide testing facilities in sub-Saharan Africa is challenging. Infrastructure and regional expertise gaps can extend the typical 24-month timeline, requiring comprehensive initial assessments.

Keywords:
Laboratorycapacity strengtheninggood laboratory practiceinsecticidequality management systemquality management systemsresearch capacity strengtheningtest facility

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Area of Science:

  • Environmental Science
  • Public Health
  • Laboratory Management

Background:

  • Insecticide resistance in malaria-endemic regions necessitates new vector control tools.
  • Sub-Saharan African facilities require enhanced capacity for insecticide testing.
  • Good Laboratory Practice (GLP) certification is the global standard for quality management systems (QMS) in non-clinical studies.

Purpose of the Study:

  • To evaluate the applicability of World Health Organization (WHO) GLP checklists and timelines in a Tanzanian insecticide-testing facility.
  • To identify factors influencing the progress towards GLP certification in a real-world setting.

Main Methods:

  • Document review of auditor GLP checklists.
  • Semi-structured interviews with facility staff at all levels.
  • Assessment of implementation in a Tanzanian insecticide-testing facility.

Main Results:

  • Auditor GLP checklists were broadly applicable, with underemphasis on computer systems.
  • Significant delays were caused by infrastructure needs, regional expertise availability, external service capacity, and training for Standard Operating Procedures (SOPs).

Conclusions:

  • Full GLP compliance is rigorous, with a standard 24-month implementation timeline.
  • This timeline is often unrealistic in low and middle-income countries due to infrastructure and regional capacity constraints.
  • A comprehensive initial gap analysis, including infrastructure and regional factors beyond WHO recommendations, is crucial for successful GLP implementation.