📖 ABSTRACT/OVERVIEW
Quality management in pharmaceutical manufacturing projects is both a regulatory obligation and a competitive imperative, with direct implications for patient safety and product compliance. This study assesses project quality management practices in pharmaceutical manufacturing companies in Lagos State, South West Nigeria. A cross-sectional survey will recruit 160 quality assurance managers, project managers, and production engineers from 15 pharmaceutical firms registered with NAFDAC in the Lagos Mainland and Agidingbi industrial zones. A validated questionnaire informed by ISO 9001 and WHO Good Manufacturing Practice (GMP) standards will assess quality planning, quality control, quality assurance, and continuous improvement practices. Descriptive statistics and regression analysis will examine the relationship between quality management maturity and project non-conformance rates. Recent NAFDAC compliance data from Lagos pharmaceutical firms indicate persistent quality failures in new product development and facility upgrade projects. Findings will support quality management system improvements and inform NAFDAC's capacity-building programs for the sector. Keywords: project quality management, pharmaceutical manufacturing, Lagos, ISO 9001, GMP compliance
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