Mabion

Our Pharmaceutical Quality System covers all stages of a drug product’s life cycle: from product development, through preclinical research and clinical trials, to commercial manufacturing. Using a Quality by Design (QbD) approach gives us a complete understanding of the development process as well as the product itself.

We consistently improve our quality management systems

As the first company in Poland, we obtained the Good Manufacturing Practice certificate for the production of monoclonal antibody drugs.
Below are examples of audits and inspections carried out by independent institutions and entities. Each of them was an opportunity to verify our standards, and improve:

Multiple GMP audits & inspections performed by external advisors

Multiple audits performed by Big Pharma

GMP Data Integrity Audits

GCP Inspections