Set Up and Qualify GMP Laboratories: A PSS Case Study
Client’s Challenge
An Ireland Client had acquired an aseptic operations facility with freeze dry product and liquid vial filling operations that was being expanded to also include a GMP microbiology laboratory. The company had outsourced all previous microbiology work, and there was limited experience on-site as to how to build and qualify a microbiology laboratory.
Our Solution
Backed by 60 years of comprehensive GMP quality testing capabilities and in-house laboratory management expertise, we have not only built and expanded many of our 800 global laboratories, but we have also delivered these same services and experience to the sites of many of the world’s largest Biopharmaceutical companies through our award-winning Eurofins PSS Insourcing Solutions network of companies. PSS brings our people to work at client facilities, under their quality systems, to design and build-out laboratories, validate equipment, establish SOP’s and LIM’s systems and perform the subsequent testing in a compliant, co-employment free, and cost-effective manner.
Results
A PSS team was established at this client’s facility, comprising 13 employees on a 3 cycle shift. This team identified a suitable laboratory location, raised change control, and liaised with construction personnel to build the new laboratory. This team worked with vendors to purchase the required equipment on behalf of the client, generated an equipment validation master plan, and set up the equipment on software systems, establishing a Laboratory Information Management System (LIMS) for the new microbiology laboratory. SOP’s were aligned or established as needed.
A training program was designed for the PSS team and the client’s full-time employees. This training supported the day-to-day testing and facility validation requirements for the microbiology, environmental monitoring, and water testing activities.
Keys to our success – why was it successful?
Our experience in establishing and operating both large and small GMP laboratories globally, coupled with our ability to hire innovative and dedicated people, resulted in the success of this project. Our on-site team lead became a trusted collaborator, and her expertise and ability to manage the team was greatly admired by our client contacts. In addition, as we took care of all hiring activities, our clients did not need to take valuable time away from the site conversion and other expansion activities to recruit for this project. Working as a flexible service model, we were able to increase team numbers when needed and all training was performed by our existing team members, which lifted additional burdens from our client and fostered a beneficial long-term partnership of trust.
