The Quality System is organized in compliance with cGMP criteria and involves every process, from the raw materials management, the manufacturing process, the on line and QC laboratory controls, until the approval and release of the lot.
The Validation Master Plan is based on a Risk Assessment approach and includes IP-OQ-PQ for:
- Manufacturing Process
- Automatic Systems for Product Control
- Laboratory Controls
- Annealing/Depyrogenating oven
- Informative Systems for Management of Production and Quality data