Medicines Regulatory Compliance Among Pharmaceutical Manufacturing Companies in the Lagos Industrial Corridor, South West Nigeria

The integrity of Nigeria's pharmaceutical manufacturing sector is contingent on stringent compliance with the National Agency for Food and Drug Administration and Control regulatory requirements, including good manufacturing practice guidelines. Non-compliance poses risks of substandard medicine production with direct implications for patient safety and public trust. This study assessed medicines regulatory compliance among pharmaceutical manufacturing companies in the Lagos Industrial Corridor, South West Nigeria. A cross-sectional facility assessment was conducted in 15 purposively selected pharmaceutical manufacturing companies. A structured compliance audit tool based on WHO good manufacturing practice and NAFDAC regulatory standards was used, covering facility conditions, documentation systems, quality control laboratories, personnel qualifications, product release procedures, and recall capabilities. Overall compliance with good manufacturing practice standards was rated as satisfactory in only 60 percent of companies. Critical deficiencies included inadequate environmental monitoring, incomplete batch documentation, and absence of validated cleaning procedures in five companies. Quality control laboratory capabilities were insufficient in three facilities. Three companies had received NAFDAC regulatory warnings within the preceding three years. Company size and export activity were positively associated with compliance scores. The study recommends strengthened and more frequent NAFDAC good manufacturing practice inspections, enhanced technical assistance programs for smaller manufacturers, and mandatory quality assurance officer training certification for pharmaceutical manufacturing companies in Lagos. Keywords: regulatory compliance, pharmaceutical manufacturing, good manufacturing practice, Lagos, NAFDAC