Quality Management of Pharmaceutical Enterprises: Economic Consequences of Non-Compliance With Good Manufacturing Practice

The article systematizes the economic consequences of pharmaceutical enterprises’ non-compliance with Good Manufacturing Practice (GMP) requirements from the perspective of operational economics and quality management. The study combines analysis of six EudraGMDP cases, three Ukrainian regulatory trajectories related to medicinal product quality, retrospective FDA evidence, and decomposition of the cost of poor quality (COPQ). The findings show that deficiencies in aseptic processing, contamination control, data integrity, validation, quality control, documentation, and equipment may result in certificate withdrawal, production restrictions, additional testing, inventory immobilisation, recalls, returns, or destruction. Ukrainian cases demonstrate that the economic outcome depends on the entire regulatory trajectory rather than solely on the final status of a batch. The documented interval between the AMPHOLIP prohibition and the decision to resume circulation was 275 days, while for NIMELGAN it was 91 days. Regulatory uncertainty therefore generates costs even when products are returned to circulation, since capital remains tied up and additional storage, testing, handling, and administrative resources are required. A COPQ decomposition is proposed that distinguishes investigation costs, CAPA, inventory hold, returns or scrap, recalls, regulatory procedures, and lost contribution margin. The study identifies the corporate data required to monetize these components through QMS, LIMS, ERP/WMS, financial accounting, and sales systems. Economic consequences are structured across three phases: detection, restriction, and final resolution. This approach distinguishes unavoidable response costs from losses dependent on the final regulatory decision, prevents double counting, identifies cost drivers, and supports managerial decisions aimed at reducing investigation time, inventory immobilisation, and recurrent quality failures. The results substantiate quality management not only as a compliance function but also as an instrument for controlling resource losses, working capital exposure, and operational efficiency in pharmaceutical enterprises