Our client embarked on a new project in California and worked through Project Delivery Partners to support with CQ Management and Facility & Equipment CQ Execution.

This project was a significant investment of over USD250 million, to increase their clinical supply capacity for their new drug products.

Project Delivery Partners were involved in developing the initial front-end Commissioning and Qualification Strategy using the ASTM E2500 risk based approach and full digital CQV execution. PDP followed through to successfully manage and execute in conjunction with the end-users of the equipment the commissioning and qualification phase for the project.

The facility encompassed high end state of the art processing technology using single use systems for this new drug substance multi-product clinical supply centre.

The facility comprised state of the art equipment, including but not limited to:

• Cold WFI generation using filtration technology
• Full single use Upstream Bioreactors
• Full single use Downstream Processing Equipment
• Full Single Use Soln Preparation / Hold / Product Pool Vessels
• Ballroom concept for Upstream & Downstream production
• Highly automated process using Delta V and MES

Project Delivery Partners were significantly involved in the initial project management & Commissioning and Qualification (CQ) Strategy including implementing the ASTM E2500 Risk based approach for C&Q of the facility and equipment.

The full life cycle CQ documentation was executed fully digitally from URS, DR/DQs, CQ execution documents to IOQ & QSR. Using the risk based approach significantly reduced the amount of testing and time to execute the CQ activities for the project.

PDP followed through to successfully manage and execute in conjunction with the client end-users the equipment for the commissioning and qualification phase for the project. The project was executed with a best in class safety programme for the critical C&Q / start-up phase.