Quality Assurance, Quality Control and Regulatory Affairs

Quality System, QMS

Fermion’s Quality System covers the requirements of ICHQ 7 ’Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients’ and Eudralex Volume 4 ’Good Manufacturing Practice guideline (GMP) Part II: Basic requirements for Active Substances used as Starting Materials’. Fermion complies with ICHQ9 (Quality risk Management), ICHQ10 (Pharmaceutical Quality system) and other ICH guidelines and follows other relevant guidelines for API manufacturing and GMP.

Control Strategy

Quality of our products is built during the product development phase. All GMP processes and relative analytical methods are validated and the product specifications are based on the impurity profiles defined by thorough investigations and scientific justifications.

The process performance and API quality are monitored and controlled during the whole lifecycle of API and evaluated by annual product quality reviews (PQR).

Quality Management Organization

The product quality is controlled by the QC laboratories and Quality Assurance on each site, working independently from manufacturing. Regulatory Affairs is a part of Quality Management ensuring tight link between the regulatory requirements and product change management.