Interview: Going beyond product compliance & expanding the quality management system
To fulfil cGMP in quality assurance for biomanufacturing, qualification and validation are essential steps demanded by several authorities. Since technologies must align with rigorous guidelines before they can be deemed suitable for use in a GMP environment, Single Use Support prioritizes ensuring that process solutions meet strict regulatory requirements.
However, the commitment goes beyond merely meeting these product-related requirements. Single Use Support takes a holistic approach to quality management, continuously advancing within global standards and management systems by integrating information security and environmental / sustainability systems. In this interview, Elisabeth Haas-Karagiannidis, Director of Quality Global, shares insights into ongoing initiatives and future plans to further strengthen quality across the organization.
Single Use Support has recently achieved the EcoVadis Silver Rating – what does this mean for Single Use Support and its customers?
Haas-Karagiannidis: We are pleased to have significantly improved our EcoVadis rating since last year. In this comparative rating, we are now among the top 15% of all rated companies. This achievement stems from our intensive focus and a series of targeted measures in all ESG (Environment, Social, Governance) sub-areas and is a clear signal of the importance we place on sustainability: We see it as a commitment to the environment and society, and in the sense of sustainable and transparent corporate governance. This also proves that Single Use Support remains a reliable partner for our customers, who are increasingly looking after sustainability in their supply chains.
What are other achievements Single Use Support had in quality management systems this year?
Haas-Karagiannidis: This year, we made several transformative decisions. Midway through the year, we decided to establish a global quality management team, with a strategic focus detached from operations, to centrally drive our integrated management system and its continuous development. It’s a unified framework that consolidates multiple management systems.
Due to strong company growth and operational expansion in recent years, it has not been possible to give equal priority to the development of internal systems. Therefore, it is important that we dedicate more effort to this now, and we are on the right track, as evidenced by the recent feedback and achievements: On the one hand by the successful initial certification according to ISO 27001 for information security, and on the other hand by the positive feedback during the ISO 9001 Quality Management surveillance audit. The auditors have attested that our system demonstrates good further advancements and a high level of professionalism, which is particularly notable for a company of our size.
Figure 1: Overview of Global Management Systems & Standards in the context of Single Use Support's progress in quality management
What sources do you rely on to drive improvements in quality management? Does this stem from the numerous audits performed by pharmaceutical companies?
Haas-Karagiannidis: We incorporate a range of inputs into our continuous improvement process. While external sources, such as customer feedback and audit results are essential, we also value internal feedback and ideas of our employees.
In the future, we intend to focus even more on cross-industry exchange. This is why we participate in committees such as Rx-360 and the BioPhorum. Furthermore, we also expect regular input from the system we implemented this year to monitor legal and regulatory requirements systematically.
What are the goals for 2026?
Haas-Karagiannidis: We won’t rest on our laurels. We plan to make further progress in terms of quality management and sustainability efforts. Regarding the integrated management system, we will focus on planned further development measures. One of these is achieving the ISO 14001 certification for environmental management by the end of 2026. We also aim to complete our system with ISO 45001 for occupational health and safety by 2027.
Alongside this, we are planning numerous targeted sustainability measures, from product development and procurement to the expansion of our reporting standards.
