Authors
Angela OLIVER1, Antoinette MELNYK1, Adebola ADEKOYA1, Laura B. MARTIN2, Neimatu ADJABUI1,3*
1: Promoting the Quality of Medicines Plus program, United States Pharmacopeia, Rockville Maryland 20582, USA
2: United States Pharmacopeia, Rockville Maryland, USA
3: Promoting the Quality of Medicines Plus program, United States Pharmacopeia, Accra, Ghana
*Correspondence: NDA@USP.ORG
Abstract
Laboratory testing to assure the quality and safety of medicines is a critical component of public health. Across Africa, national regulatory authorities are challenged by a lack of sufficient capabilities within their national quality control laboratories (NQCLs) to perform analyses in a consistent, reliable, and accurate manner. The United States Agency for International Development funded-program, Promoting the Quality of Medicines and its successor Promoting the Quality of Medicines Plus, both implemented by United States Pharmacopeia, have worked to strengthen the testing capabilities of NQCLs in African countries. Their technical assistance aligned NQCLs’ operational practices and testing services with international standards and best practices and resulted in third-party recognition of capabilities and competence. This commentary provides a retrospective of key achievements of NQCLs in three West African countries, Ghana, Mali, and Nigeria, and illustrates success in addressing challenges through a complex multiyear venture. The commitment and dedication of NQCLs and their NRAs has resulted in international levels of compliance and competency.
Keywords: national quality control laboratories, laboratory strengthening, sustainability, ISO/IEC 17025, WHO Prequalification, Ghana, Mali, Nigeria, West Africa
Graphical abstract
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