Definition and Qualification of a New WFI System

In order to increase its production capacity, our client had to install a new water for injection system. The water for injection (WFI) system consists of two main sub-components, a water for injection generator, as well as a storage tank and distribution loop.

Genipro was commissioned to provide technical writing and execution services for GMP qualification documents associated with the new water for injection (WFI) production, storage and distribution system. The new WFI system was to be designed, built, qualified, operated and maintained by the client in accordance with GMP regulatory requirements and expectations.

The main challenge of this project was to adapt to the project schedule which was modified several times following delays in the delivery of equipment. The qualification of the system demonstrated that the equipment met the requirements and specifications.