Quality policy

At Mabion S.A., we are committed to delivering high-quality biological products, as well as analytical and research and development services that meet our clients’ expectations and regulatory requirements. Our primary goal is to ensure the safety, efficacy, and quality of our products. At the same time, we strive to adhere to the principles of sustainable development and implement innovative solutions that are in line with current technological trends and meet our clients’ requirements in this regard.

The Quality Policy of Mabion S.A. is based on the following pledges, which form the foundation of our business and guarantee the highest quality of products:

• Compliance with regulations and quality standards
  We abide by the applicable legal regulations, GMP (Good Manufacturing Practice) standards, and regulatory guidelines such as ICH, EMA, FDA, and WHO to ensure full compliance of our processes and products.
• Data integrity and security
  We make every effort to ensure complete integrity, security, and accuracy of data in all our operations. We ensure compliance with the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) in every aspect of our business.
• Quality risk management
  We apply a systematic approach to risk management, identifying and minimising risks that can affect the quality of products and services at every stage of their life cycle.
• Continuous improvement
  We implement principles of continuous improvement in every aspect of our business, using data from audits, risk analysis, scientific research, and customer feedback to optimise our processes and products.
• Employee commitment
  We believe that the high quality of our products depends on the dedication and competence of our team. Accordingly, our employees have a real influence on the shape and course of the processes at the company. We ensure that our staff are properly trained, have the necessary qualifications, and understand their roles and responsibilities in quality-related processes.
• Partnership and transparency
  We communicate openly and transparently with our clients, suppliers, and regulatory authorities, building long-term relationships based on trust and cooperation.
• Innovation and technological development
  We invest in modern technologies and upskilling of our employees to provide the most advanced solutions in manufacturing of biological medicines.
• Sustainable development
  In our business, we are guided by the principles of sustainable development, taking care of the environment, efficient use of resources, and waste minimisation.
• Patient in the centre of attention
  We operate with patients in mind, ensuring that our products are safe, effective, and manufactured according to the highest quality standards.

The Quality Policy is an integral part of our Pharmaceutical Quality Management System (QMS) and serves as the foundation for all our operations. All employees of Mabion S.A. are responsible for adhering to the principles of the Quality Policy and implementing them in their daily tasks.