Evaluation of Compliance with NAFDAC Good Manufacturing Practice Guidelines at Small-Scale Pharmaceutical Manufacturers in Ogun State

Small-scale pharmaceutical manufacturers represent a critical component of Nigeria's domestic medicine production capacity. In Ogun State, South West Nigeria, a cluster of small and medium pharmaceutical manufacturers operates under the regulatory oversight of NAFDAC. Compliance with Good Manufacturing Practice requirements is fundamental to the safety and quality of products from these facilities. This study evaluated GMP compliance at fifteen small-scale pharmaceutical manufacturers in Ogun State using the WHO GMP audit tool adapted for developing country manufacturing facilities. Facility assessments were conducted by trained pharmaceutical chemistry assessors across key GMP domains including premises and equipment, quality management systems, production documentation, laboratory controls, and personnel training. Overall GMP compliance scores ranged from 41 to 78%, with a mean of 59%. The lowest compliance scores were observed in quality management systems and documentation. Batch manufacturing records were incomplete in 67% of facilities, and validated cleaning procedures were absent in 53%. In-process quality control testing was systematically documented in only 40% of facilities. Personnel training records were inadequate in 73% of assessed manufacturers. Higher compliance was positively correlated with facility size and the presence of a qualified person with postgraduate pharmaceutical training. These findings identify priority areas for GMP capacity building support to small-scale pharmaceutical manufacturers in Ogun State. Keywords: Good Manufacturing Practice, pharmaceutical manufacturers, Ogun State, NAFDAC, GMP compliance.