Set Up And Qualify GMP Laboratories

A client in Ireland acquired an aseptic operations facility with plans to expand into GMP microbiology laboratory services, despite having previously outsourced all microbiology work and lacking in-house expertise. Eurofins Professional Scientific Services (PSS) addressed this challenge by deploying a dedicated team of 13 employees working in three shifts to the client’s site. The team managed the entire laboratory setup process, including identifying a suitable location, coordinating with construction personnel, and overseeing the build-out of the new lab.

Eurofins PSS handled equipment procurement, developed an equipment validation master plan, and implemented a Laboratory Information Management System (LIMS) to ensure efficient and compliant sample tracking and data management. Standard Operating Procedures (SOPs) were established or aligned as needed, and a comprehensive training program was created for both the PSS team and the client’s permanent staff. This training covered daily testing, facility validation, environmental monitoring, and water testing activities.

The success of the project was attributed to Eurofins PSS’s extensive experience in establishing GMP laboratories globally, their ability to recruit and manage skilled personnel, and the leadership of the on-site team lead, who became a trusted collaborator for the client. By managing all hiring and training, Eurofins PSS allowed the client to focus on other expansion activities. The flexible service model enabled team scaling as needed, with all training performed internally, further reducing the client’s workload and ensuring a smooth laboratory qualification process.