Set Up And Qualify GMP Laboratories

Establishing an in-house GMP microbiology laboratory presents a complex challenge, particularly for companies with limited prior experience. This case study details how a new facility was set up and qualified, highlighting the critical steps involved in a successful transition from outsourced to on-site operations. By identifying a suitable location and working with vendors to procure essential equipment, the team successfully built out a new laboratory. The process included developing a comprehensive equipment validation master plan and setting up a new Laboratory Information Management System (LIMS) to ensure compliant testing. Discover how this strategic approach, backed by specialized expertise in hiring and training, helped the client overcome a key operational challenge, streamline processes, and maintain rigorous quality standards. Learn more about the keys to success and how the right partnership can facilitate your own operational goals.