Adoption of international good manufacturing practices in the Nigerian pharmaceutical industry: promising results from a decade of investment

Background: Despite Nigeria's robust pharmaceutical sector, no local manufacturer there achieved World Health Organization (WHO) prequalification before 2011. This contrasts with countries like South Africa, Morocco, Kenya, and Uganda, which have WHO-prequalified products and can participate in global medicine tenders. This study aimed to analyze successful initiatives supporting good manufacturing practices (GMP) standards in Nigeria, identify challenges hindering WHO prequalification, and proposed recommendations to enhance GMP compliance and facilitate WHO prequalification, aiming to strengthen the Nigerian pharmaceutical industry and improve access to quality medicines. Methods: A desk review was conducted to examine initiatives supporting adoption of GMP standards in Nigeria. rapid qualitative analysis techniques were used to interview key personnel involved in these initiatives. Interview data were summarized into predefined domains aligned with the interview guide and organized into a matrix, enabling descriptive analysis to highlight key points, narrative synthesis to construct a cohesive account of experiences, and interpretative synthesis to derive implications from the data. Results: Four major initiatives provided technical support to local pharmaceutical manufacturers, facilitating progress towards GMP compliance and enabling the first Nigerian pharmaceutical manufacturer to obtain World Health Organization prequalification (WHO PQ). Initiatives included: (1) WHO project from 2011 to 2014; (2) the Promoting the Quality of Medicines (PQM) program (2009–2020); (3) the PQM + program (2019–2025), both funded by the United States Agency for International Development (USAID) and implemented by the U.S. Pharmacopeia; and (4) a GMP roadmap project by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the United Nations Industrial Development Organization (UNIDO) (November 2018–May 2019) Conclusion: Collaboration among NAFDAC, local manufacturers, the WHO PQ Team, and other partners enabled successful implementation of these programs, culminating in WHO PQ of Swiss Pharma Nigeria Limited’s zinc sulfate dispersible tablets on June 6, 2023–the first in West Africa. However, significant challenges persist, including insufficient understanding of WHO PQ requirements, inadequate GMP-compliant facilities, and financial constraints. Addressing these issues requires targeted interventions focused on GMP awareness, infrastructure investment, regulatory support, and harnessing Nigeria’s potential as a pharmaceutical manufacturing hub.