Objective & context
Develop the medicine traceability system for products following new legislation requirements, by the Implementation and validation of Serialization and Aggregation Technology for an Italian customer.
Based on FDA-EMA “Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use” we were in charge of:
- Support for project approach definition (Project Risk Assessment)
- Qualification of Supplier
- Replacement of the previous punch printing system with an Ink-jet printing system, configurable via SW and able to manage the new label box containing Data Matrix code.
- The development of the Management system, to allow tracing/aggregation of serial codes assigned to “closed” boxes/pallets and Site central information archive implementation.
- The Implementation of a manufacturing data communication Interface, from ERP System to the line, by using the sites central database.
- Issue of documentation and execution of validation activities