Quality management
Quality System, QMS
Fermion’s Quality System covers the requirements of ICH Q7 ’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 ICH Q9 (Quality risk Management), ICH Q10 (Pharmaceutical Quality system) and follows all relevant guidelines (ICH and others) for API manufacturing and GMP.
Control Strategy
Quality of our products is built during the product development phase. All GMP processes and related analytical methods are validated, and the product specifications are based on impurity profiles defined by thorough investigations and scientific justifications.
The process performance and API quality are monitored and controlled during the whole lifecycle of the API, and evaluated in 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 a tight link between the regulatory requirements and product change management.
Inspection history
Fermion Oy has a long inspection history, with the first successful FDA inspection taking place already in 1979. Fermion is regularly inspected by the FDA, EU Inspections by FIMEA (Finnish Medicines Agency) and also by competent authorities from Japan, South-Korea, Mexico and Brazil.
Fermion’s Quality Management System and GMP compliance is also annually audited by several customers.
GDP
Fermion has the status of Known Consignor and Security Approval given by Finnish Transport Safety Agency (TRAFI).
Fermion complies with Guideline on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01).