Sustainability Roadmap as a Strategic Driver in the Pharmaceutical Industry - Integrating Failure Modes, Effects, and Criticality Analysis (FMECA) to Assess Risks and Opportunities in Sustainable Transformation

The increasing awareness of climate change, resource scarcity, and regulatory pressure has transformed sustainability into a strategic imperative, especially in highly regulated sectors such as the pharmaceutical industry. This thesis investigates the role of the Sustainability Roadmap as a driver of environmental transformation, with a specific focus on the integration of Failure Modes, Effects, and Criticality Analysis (FMECA) to evaluate risks and opportunities in sustainable innovation. The case study analyzed is PharmaComp, a multinational pharmaceutical group that has developed a structured roadmap to achieve ambitious climate targets: a 51% reduction in Scope 1 and 2 emissions by 2030 compared to 2023 levels and carbon neutrality by 2030 through a mix of internal abatement projects and offsetting. The research is divided into two main parts. The first examines the design and strategic pillars of PharmaComp’s roadmap—energy transition, digitalization, and circular economy—together with enabling tools such as scenario analysis, investment planning, and prioritization matrices. Emphasis is placed on the balance between environmental ambition and financial sustainability, highlighting the use of sustainability-linked financing, CAPEX optimization, and performance monitoring through KPIs. The second part focuses on the risks associated with implementing sustainability initiatives in pharmaceutical production environments, where technological changes can introduce uncertainty, compliance challenges, and operational vulnerabilities. To address these complexities, the thesis applies FMECA as a structured methodology to identify failure modes, assess their effects on quality, safety, and sustainability, and prioritize mitigation actions. Originally developed in aerospace and defense, FMECA is here adapted to evaluate the reliability and regulatory robustness of sustainability-oriented projects. Two case studies illustrate this approach: the adoption of reverse osmosis systems for Water for Injection (WFI) at a German site, aimed at reducing energy demand compared to traditional distillation, and the solvent recovery of isopropanol and acetone at an Italian facility, designed to improve circularity and minimize hazardous waste. In both cases, detailed FMECA analyses, including risk matrices and Pareto charts, demonstrated that while sustainability initiatives generate environmental and economic benefits, they must be carefully evaluated to avoid compromising Good Manufacturing Practices (GMP) and operational integrity. The findings confirm that sustainability cannot remain a parallel initiative or a mere communication exercise but must be embedded into the company’s governance, risk management, and operational culture. By integrating FMECA into its roadmap, PharmaComp demonstrates how environmental transformation can be pursued with the same rigor as quality and process reliability, turning risks into opportunities and innovation into measurable impact. This thesis thus contributes to the broader debate on how the pharmaceutical industry can align decarbonization, resource efficiency, and regulatory compliance, providing a replicable model for other sectors.