We have a comprehensive quality system designed, documented, implemented, controlled and resourced with staff, equipment and facilities.
This system provides assurance that biopharmaceuticals are consistently manufactured at the appropriate quality level required for their intended use, in compliance with your standards and international authorities regulations.
This quality is attained thanks to our staff's involvement and commitment to achieve excellence at all levels of Eurogentec's Biologics Business Unit.
The concept of Quality Assurance is wide-ranging and covers all matters that individually or collectively influence the quality of the product. We are organized to ensure that the safety, integrity and quality of medicinal products conform to current GMP's.
Our Quality Assurance team is responsible for:
- Standard operating procedures review and approval
- cGMP trainings
- Equipments and premises compliance with cGMP
- Internal, supplier's and subcontractor's audits
- Raw materials release
- Products release to client supported by batch records
- Validation protocols review and approval according to a validation master plan, including URS / DQ / IQ / OQ/ PQ
A Qualified Person (QP) ensures that each batch is released in compliance with the appropriate regulations. A release certificate signed by the QP accompanies each batch.