The Proceedings of the BIRS Community

Funder Acknowledgement

Educational support provided by the Merck Foundation and most recently through a capacity build-ing effort funded by the Bill and Melinda Gates foundation, grant # 41000460.


In Nigeria, pharmaceutical manufacturing is regulated by the Pharmacists Council of Nigeria (PCN) and the National Agency for Food and Drug Administration and Control (NAFDAC). The PCN Act gave the regulatory authority the mandate to register all pharmaceutical premises. With the later creation of NAFDAC to regulate drugs, comes the dual regulatory authority on those premises by both government agencies who carry out Good Manufacturing Practice (GMP) inspections in the process of carrying out their mandates. Dual regulatory authority and inspections puts a considerable inspection burden on the manufacturers and even the regulators. This study examined the inspection tools used by each agency, the acts setting them up, as well as best practices around the world on inspections and regulatory frameworks. The goal was to identify regulatory practices that lessen the burden of inspection on pharmaceutical manufacturers and regulators. A review of the agencies’ inspection tools showed both PCN and NAFDAC utilize the World Health Organization (WHO) guidelines and templates on inspections. The primary function of PCN is the regulation of pharmacy and pharmacy practice with added responsibility to register and certify premises for pharmaceutical manufacturing purposes. NAFDAC’s primary role, on the other hand, is to regulate pharmaceutical products. Both PCN and NAFDAC carry out this regulatory function on pharmaceutical manufacturing premises through Good Manufacturing Practice (GMP) inspections. This study showed an overlap in the agencies’ functions with respect to the inspection of pharmaceutical manufacturing premises before certification, thus creating a duplication of regulatory functions. Inter-agency collaboration would be of great value to lessen the burden on the manufacturers from frequent GMP inspection visits.