Managing The Operational Efficiency Of Pharmaceutical Enterprises Based On The Lean Manufacturing Concept

The article provides a theoretical justification and develops a methodological approach to managing the operational efficiency of pharmaceutical enterprises based on Lean Production. The relevance of the study is determined by the need to improve productivity, quality, resource efficiency, and operational resilience under strict regulatory requirements, wartime risks, supply chain disruptions, and resource shortages. The research applies systemic, process-based, and risk-based approaches, along with analysis, synthesis, comparison, generalisation, and systematisation. The operational efficiency of a pharmaceutical enterprise is defined as its ability to consistently transform material, technological, informational, and human resources into high-quality and accessible medicines at the lowest reasonably achievable total cost while ensuring GMP compliance, patient safety, and continuity of supply. The main types of waste in pharmaceutical manufacturing, their industry-specific manifestations, appropriate Lean tools, and implementation safeguards are systematised. It is established that mandatory procedures related to documentation, laboratory control, qualification, validation, deviation investigation, and change management should not be automatically classified as waste, as they create regulatory and patient value. A six-level operational efficiency management model covering strategic, regulatory, quality, process, instrumental, digital, cultural, and competency dimensions is proposed. An eight-stage Lean transformation approach is developed, ranging from organisational readiness assessment and pilot value-stream selection to standardisation and scaling. The scientific novelty lies in integrating Lean tools with the pharmaceutical quality system, quality risk management, and the “quality gate†principle. The practical application of the proposed approach enables pharmaceutical enterprises to reduce non-value-adding activities while avoiding unacceptable risks to product quality, regulatory compliance, patient safety, and medicine availability.