High quality laboratory and field data are essential for manufacturers, the World Health Organization (WHO) and regulatory authorities to allow vector control product development, assess performance and approve market introduction.
Until recently, most facilities conducting vector control product testing lacked any formal Quality Management System (QMS) – a system for internal quality control and quality assurance. Lack of a formal QMS made it impossible to fully reconstruct studies to determine whether they had been conducted correctly, without any deviations from the study plan or Standard Operating Procedures (SOPs).
Funding partner
GLP certification
In 2010, a project was initiated by IVCC and Innovation to Impact (i2i) to provide the tools that enable collaborating research facilities in Africa and the UK to develop and implement a QMS compliant with the OECD principles of Good Laboratory Practice (GLP) to obtain GLP certification.
The project moved into a new phase supporting GLP certification in 2016 with funding from the Bill & Melinda Gates Foundation. Funds have been made available to collaborating institutions both for the GLP certification process and for infrastructure improvements required for full GLP compliance.
Eight collaborating research facilities were supported by IVCC towards GLP certification: 3 facilities in East Africa, 4 facilities in West Africa and 1 facility in the UK.
Between 2011 and 2018, five GLP training workshops were held (one in the UK and four in Africa). Ongoing mentoring was given on QMS development, including the development of SOPs.
As of 2023, five Africa research facilities have been granted GLP certification by the South African National Accreditation System (SANAS): the PAMVERC–KCMUCo facility, Tanzania; Ifakara Health Institute, Tanzania; the Centre Suisse de Recherches Scientifiques (CSRS), Côted’Ivoire;the CREC/LSHTM facility in Benin; and Institut Pierre Richet (IPR) VCPEC facility in Bouake, Côte d’Ivoire. In addition, the Liverpool Insect Testing Establishment is a member of the UK GLP compliance monitoring programme. The remaining facilities are progressing well towards full GLP compliance and are expected to become GLP certified by the end of 2023.
The eight research facilities supported by IVCC towards GLP certification form part of a larger network of collaborating trial facilities in Africa. Combined, they help IVCC and our industrial partners to assess cross-resistance risk to Active Ingredients and to evaluate the performance of prototype and final products. This includes laboratory trials using well-characterised insecticide susceptible and resistant strains of several Anopheline malaria vector species, semi-field cage trials, small-scale experimental hut trials, and community village-scale trials.
Although much of the current focus of product testing is on the evaluation of Insecticide Treated Nets (ITNs) and Indoor Residual Spraying (IRS) formulations, IVCC’s network of collaborating trials facilities can also evaluate other types of vector control products including Attractive Targeted Sugar Baits (ATSB®), larvicides, and topical and spatial repellents. For some of the collaborating facilities that are not part of the GLP project, IVCC is providing advice on the development of quality management systems to help assure the generation of reliable data.