From Design To Operation: Supporting GMP Facility Readiness
For more than 20 years, Eurofins PSS Insourcing Solutions® has partnered with biotech and pharmaceutical companies to successfully validate and open new or remodeled facilities, meeting regulatory requirements. With a proven track record across numerous facility projects, our flexible, client-focused model ensures seamless integration with internal teams and third-party vendors, delivering high satisfaction and long-term partnerships.
Eurofins PSS provides comprehensive support throughout the entire lifecycle of a GMP facility, including construction, validation, and everyday operations. From initial design and layout planning to equipment selection and qualification, we help clients make informed decisions that align with their unique needs, timelines, and regulatory expectations. We offer robust validation and qualification services, covering installation and troubleshooting, initial validation, and ongoing compliance studies -- such as Environmental Monitoring Performance Qualification (EMPQ), water, and gas testing. Depending on the client’s needs, our PSS teams offer the flexibility to either support or fully manage activities.
Beyond facility validation and qualification, our expertise extends into the implementation of quality control systems, for both the facility and products it generates. We have supported countless clients with routine quality testing. Our collaborative approach ensures that all systems are designed for long-term compliance and efficiency. Documentation and recordkeeping are handled with the same rigor, and we always maintain audit-ready status. Eurofins teams also bring tremendous value through our Operational Excellence program, which have saved clients over $37 million since 2017.
A key differentiator of Eurofins PSS is our people and our approach to training personnel. We prioritize building a sustainable knowledge base by developing a core group of subject matter experts who can take ownership of future training and re-training efforts with client approval. This approach reduces the burden on internal teams and ensures continuity as operations scale. Our staff are fully trained to operate within the client’s quality systems from day one. While we typically work within existing documentation systems, we can also provide guidance on best practices and support the creation of training materials and SOPs. In some cases, we have even led training efforts of client’s own FTEs on subjects, such as PPE usage, environmental monitoring sampling, sample scheduling, and documentation.
As facilities mature, we can support maintenance, day-to-day operations, and continuous improvement initiatives. This is a key reason why we have continuously served our first clients for over 20 years and have never lost a program due to client dissatisfaction. We understand the pitfalls and importance of timing in building, qualifying, and running facilities; and we have the project management expertise to ensure that our client’s new facility projects stay on track and meet compliance with regulatory standards, including ISO, FDA, and EMA. Our flexible delivery model, value add programs, and access to the broader Eurofins network makes PSS a valuable partner in building and sustaining compliant, efficient, and future-ready GMP facilities.