Demographic determinants of adherence to good manufacturing (Gmp) and good distribution practices (Gdp) in the Api pharmaceutical sector

Ensuring consistent adherence to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) is essential to product quality and regulatory trust in the Active Pharmaceutical Ingredient (API) sector. However, limited evidence exists on whether individual demographic characteristics meaningfully influence compliance behavior. This study investigates whether age, gender, and work experience predict GMP and GDP adherence and evaluates the extent to which system-level factors may play a more decisive role. Guided by the Theory of Planned Behavior (TPB) and the Quality Compliance Framework (QCF), a quantitative cross-sectional survey was conducted among 1,000 personnel working in quality and operations functions. Descriptive statistics, regression analysis, and Structural Equation Modeling (SEM) were used to assess the relationships among demographics, compliance indicators, and organizational influences. Results show that age, gender, and work experience have no statistically significant effect on GMP or GDP compliance (p > 0.05). Instead, organizational support, training quality, and quality awareness emerge as stronger enablers of compliant behavior. These findings highlight that compliance culture is shaped primarily by institutional systems rather than individual traits. The results also contribute to the broader body of literature on quality management by emphasizing the dominant role of system-level determinants of compliance, further substantiating the importance of institutional design and governance structures within regulated environments. The study contributes empirical evidence to support system-focused regulatory strategies, inform capacity-building initiatives, and guide the development of equitable, evidence-based quality assurance mechanisms in emerging pharmaceutical markets.