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


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.


good manufacturing practices