BfArM - Federal Institute for Drugs and Medical Devices

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Project visit to Sierra Leone and Liberia

As part of the GHPP LabTrain project, the national pharmaceutical authorities in the West African partner countries Ghana, Liberia, Sierra Leone and Gambia are receiving targeted support to improve their quality control laboratories (QCLs). A comprehensive survey on quality management and internal processes was conducted in advance, accompanied by an intensive exchange with the partner laboratories. In October 2023, an initial on-site visit was made to the two laboratories in Sierra Leone and Liberia to gain a detailed insight into their day-to-day operations.

Sierra Leone

In Sierra Leone, the representatives of the LabTrain team from BfArM and InphA visited the Pharmacy Board of Sierra Leone (PBSL) in Freetown. The GHPP LabTrain project was presented there, followed by an exchange and a presentation of the PBSL's management system. The team visited the laboratory and followed the process of processing a sample from its initial acceptance to the final issuing of the certificate of analysis. It turned out that a management structure has already been established, but that it does not yet fully comply with the guidelines. In addition, a need for action was identified with regard to documentation and laboratory equipment, some of which is outdated. Financial constraints and a lack of expertise in the maintenance of instruments are further challenges that need to be addressed.

Das GHPP LabTrain Team mit Projektpartnern des PBSL
Das GHPP LabTrain Team mit Projektpartnern des PBSL Source: BfArM/LabTrain

Liberia

In Liberia, the visit to the Liberia Medicines and Health Product Regulatory Authority (LMHRA) in Monrovia continued. The associated QCL is located about an hour outside the capital. The main components of the quality management system (QMS) are integrated in the laboratory and function relatively well. A need for improvement was identified in the documentation in order to be able to find documents quickly through systematic filing. The QCL has comparatively modern equipment, supported by materials from the United States Agency for International Development (USAID) and the U.S. Pharmacopeia (USP). The personnel capacity in the laboratory is considered sufficient. The maintenance and calibration of equipment does not appear to be a major problem for the LMHRA, as technicians are regularly on site. Nevertheless, employees still lack the ability to carry out simple steps to rectify problems independently.

Das GHPP LabTrain Team mit Projektpartnern der LMHRA
Das GHPP LabTrain Team mit Projektpartnern der LMHRA Source: BfArM/LabTrain

Conclusion

The on-site visit enabled the LabTrain team to gain a direct and authentic insight into the work of the partner laboratories. This had only been possible to a limited extent due to the mainly virtual exchange and the digital survey in advance. The visit was able to overcome this limitation and was therefore of great importance for the project and its further progress. The knowledge gained enabled the planned structural development plans to be tailored more specifically to the individual needs of the laboratories, allowing for improved support in the development of the respective QCLs.