The challenge our client faced

Our client had acquired an aseptic operations facility with freeze-dry product and liquid vial filling operations. This was to be expanded and include a Good Manufacturing Practice (GMP) microbiology laboratory. As the company had outsourced all of its previous microbiology work, there was limited experience on-site in building and qualifying a microbiology laboratory.

Our solution to their problem

PSS® has 60 years of comprehensive GMP quality testing capabilities and in-house laboratory management expertise. We have not only built and expanded many of our 900 global laboratories, but we have implemented this experience on the sites of many of the world’s largest biopharmaceutical companies via the Eurofins PSS Insourcing Solutions® network of companies.

We deploy our own people to work at client facilities, observing that client’s quality systems to design and build out laboratories, validate equipment, establish standard operating procedures (SOP) and laboratory information management systems (LIMS), and perform the required testing in a compliant, co-employment-free, cost-effective manner.

The results

PSS® established a team of 13 employees working a three-cycle shift at our client’s facility. This team identified a suitable laboratory location, raised change control, and liaised with construction personnel to build the new laboratory.

Our team worked with vendors to purchase the required equipment on behalf of the client and generated an equipment validation master plan. The equipment was set up on software systems, establishing a LIMS for the new microbiology laboratory, and SOPs were aligned or established as needed.

A training programme was developed for the PSS® team and client’s full-time employees to support the day-to-day testing and facility validation requirements for the microbiology, environmental monitoring, and water testing activities.

The keys to our success

Our experience in establishing and operating both large and small GMP laboratories globally, coupled with our ability to hire innovative, dedicated people contributed to the success of this project.

• Our on-site team lead became a trusted collaborator. Her expertise and ability to manage the team was recognised by our client contacts.
• As we took care of all hiring and recruitment, our client could focus on the task at hand of the site conversion and expansion activities.
• Our flexible service model enabled us to increase team numbers when required.
• All training was carried out by our existing team members, which alleviated additional burdens from our client and fostered a beneficial long-term partnership of trust.