Risk-Based Inspections and Product Quality: Evidence from Nigeria’s Pharmaceutical Manufacturing Sector
Abstract:
This study examines how Nigeria’s recent pharmaceutical regulatory
reforms have translated from policy to practice within the local manufacturing
sector, following the National Agency for Food and Drug Administration and
Control’s (NAFDAC) attainment of WHO Global Benchmarking Tool Maturity Level 3.
The reforms—centred on Good Manufacturing Practice (GMP), Quality Management
Systems (QMS), digital platforms such as the NAFDAC Automated Product
Administration and Monitoring System (NAPAMS) and the Ports Inspection Data
Capture and Risk Management System (PIDCARMS), and emerging traceability
initiatives—were designed to strengthen compliance, improve transparency, and
enhance product quality. A descriptive cross-sectional survey was conducted
among 122 of 182 NAFDAC-approved pharmaceutical manufacturers, yielding a
response rate of 67%. The structured questionnaire contained multiple-choice
and Likert-scale items and demonstrated strong internal consistency (Cronbach’s
α = 0.82). Data were analysed using descriptive statistics, Spearman’s rank
correlations, multiple regression, and chi-square tests. The results indicated
high awareness and adoption of GMP (87.7%) and QMS, substantial engagement with
NAPAMS (70.5%), but comparatively lower adoption of PIDCARMS (47.5%),
highlighting gaps in traceability readiness. Correlation and regression
analyses confirmed inspection effectiveness as the strongest predictor of
regulatory outcomes, significantly associated with transparency, overall
effectiveness, and improved product quality. Chi-square analysis further
revealed differences in perceptions of product quality across professional
roles. The findings demonstrate that while Nigeria’s regulatory system has
achieved structural credibility, sustained impact will require targeted support
for small- and medium-sized manufacturers, phased implementation of
traceability systems, and continuous monitoring of outcomes beyond
documentation milestones.
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