Quality > Quality Unit
Quality & Compliance is a Corporate function which makes use of staff specialised in, for example, Regulatory Affairs, Quality Management, Quality Control Management. Each site has a Quality Unit to which the site Quality Assurance and Quality Control answer. The Quality Unit Manager is the Qualified Person of the site.
The quality management system is aimed at putting into effect all the preventative actions which ensure the attainment of product quality, with regard to GMP and regulatory constraints. This means supervising the projects/products starting from the process development stage up to its realization in suitably designed, qualified and maintained plant, equipped with evolved control and automation systems.
Some activities such as validation and qualification of plant and systems, as with the qualification of suppliers, find the greater part of resources in the central corporate function.
A procedural system based on guide lines and specific operational site procedures guarantees compliance, also with flexibility.
Data Integrity, Quality Risk Management, Continuous Improvement are fully implemented in the F.I.S. Quality System.
The sites receive dozens of client audits which help with the continuous improvement of the system.