The Quality System  present in FIS, combine national (AIFA) and international regulation (21 CFR 210-211 per US FDA e EC Guide Part II ICH Q7A) for  the operation in cGMP production of the API’s.

The Quality System includes the QA (Quality Assurance), the QC (Quality Control) and the Regulatory Affairs where the functionality and the accountability of each unit is separated from the other.

The system is aimed at a continuous improvement of the quality as well as to a proactive evaluation of some cost benefit by planning which could be the potential deviation and relative corrective action that needs to be done.
 
The Quality System is fundamental to manage the supply chain.