The Challenge Faced
- New pharmaceutical packaging facility bailout with an aggressive timeline
- State of the art MPS packaging lines integration
- Implementation of serialization (track-and-trace) program to meet the regulation deadline
- Creation of new packing process and procedures
PharmAllies’ Deliverables
- Managed the packaging facility startup
- Commissioned and validated four MPS packing lines
- IQ/OQ and PQ development and execution
- Managed the implementation of the serialization program
- Integration, validation and procedure development
- Installation and validation of a new WonderWare Building Monitoring System
Assessment
PharmAllies successfully managed a new pharmaceutical packaging facility buildout with an aggressive timeline. Some key areas of focus were integrating state of the art MPS packaging lines and implementing a serialization (track-and-trace) program to meet regulatory deadlines. In addition, to optimize efficiency, PharmAllies decided to create a new packing process and procedure.
PharmAllies successfully commissioned and validated four MPS packing lines, which included the IQ/OQ/PQ development and execution. Our consultant was able to drive the implementation of a serialization program as well as the installation and validation of the Wonderware Building Monitoring System.
