GLP

GRAHAM SMALL: My name’s Graham Small. I’m the trials quality and project support manager for IVCC. Manufacturers, WHO, and regulatory authorities depend on the quality of data generated for the testing of vector control products. But until recently, the sites conducting these tests didn’t have any formal quality management systems in place. So it was impossible to verify the quality of the tests that they were conducting. To remedy this, IVCC and WHO have launched the project to GLP certify sites in Africa, Asia, and the Americas. GLP, Good Laboratory Practise, has been considered to be the gold standard for the testing of pesticide products for decades.

OEC GLP is a set of quality management systems that governs the quality of studies and makes sure that the data generated is reliable, reproducible, and importantly also auditable. So if there are any questions about how studies are being conducted, then those can be independently verified. Importantly also, GLP is recognised internationally. So WHO and regulatory authorities can depend on the quality of data generated to GLP. The implementation of GLP helps to prevent the occurrence of false negative results. A false negative result in the context of vector control products will be a product that should kill mosquitoes. But because of the way a study’s being conducted, they survive. GLP also helps to prevent the occurrence of false positive results.

So again, in the context of vector control products, a false positive result would be a product that shouldn’t kill mosquitoes. But because of the way the study is being conducted, it does kill them. When a facility has implemented GLP, it helps to limit the waste of resources because it helps to prevent studies having to be repeated because they’ve been conducted incorrectly. The implementation of GLP also helps to ensure that the results generated during studies are independent of the time they were conducted, the facility they were conducted in, but also within the facility is independent of the staff member conducting the study. GLP controls the way the studies are planned in terms of the study protocol and standard operating procedures, SOPs.

It controls how the study is conducted, how the results are recorded, and then finally, how they’re reported and archived. In collaboration with IVCC, WHO, and Innovation to Impact, I2I, a programme has been initiated to support sites across Africa, Asia, and the Americas towards GLP certification and also to develop best Practise standard operating procedures, SOPs, which cover the test methods described in WHO’s testing guidelines. To support the African sites towards GLP certification, it’s necessary also to help them to improve their infrastructure and purchase equipment so that they can become fully GLP compliant.

This has also had the result that it has strengthened the capacity for research at African institutions so that they are able to deliver for companies developing vector control products, not only for GLP studies for their vector control product evaluations at WHO, but also helping companies with their research and development. Good Laboratory Practise, GLP, is a set of organisational requirements that build into a quality management system. It’s been considered to be the gold standard for the testing of pesticidal products for many years. And it helps to support the quality and validity of test data. So a research facility that has implemented GLP can run studies that are of good quality and generate data that can be reliable, reproducible, and auditable.

My experience working with facilities in Africa is that considerable support is required to improve infrastructure, the labs and insectary space, but also helping them to purchase equipment for GLP compliance purposes. Their purchase of equipment can also be challenging. So often the equipment isn’t available in country. And the maintenance and servicing equipment calibration can also prove challenging. As well as transferring funds for infrastructure and equipment purchases, IVCC has been helping to develop the quality management systems that’s necessary for GLP compliance, including a whole suite of standard operating procedures.

In addition, IVCC has been mentoring staff members in terms of delivering training to them so that they become fully GLP aware and know exactly what they need to do to maintain GLP compliance in their day-to-day work. Once these facilities obtain GLP certification, they can offer world-class services to industry for the testing of their vector control products. In addition, the GLP certification will mean that their data will be recognised by regulatory authorities worldwide. And importantly for this project, the data will be recognised by WHO prequalification for the evaluation of vector control products.

Information on the requirements for GLP compliance can be found on the OECD GLP website that lists all of the principles and also has advisory documents which advise on the necessary quality management system and other processes for GLP compliance. So for industry and for people wanting to find out which sites are moving towards GLP certification and have attained their GLP certification, they can go to the Innovation to Impact I2I website, where they can find all of this information.