When GlaxoSmithKline launched a new phase III vaccine facility, they trusted ALTEN to manage 122 validation protocols and coordinate 25 systems start-ups. The result? Full compliance with Annex 15 and a seamless path to production readiness.
For its new phase III vaccine production building, GlaxoSmithKline Vaccines partnered with ALTEN Technology to conduct a full pack of validations. ALTEN Technology was entrusted with the critical task of performing 122 validation activities and 25 risk assessments for the building’s start-up, all in compliance with Eudralex Annex 15.
The project encompassed a wide range of services delivered by ALTEN Technology. These included comprehensive Performance Qualification (PQ) activities, from preparing protocols and executing runs to writing final reports. ALTEN Technology also handled the creation of all necessary technical reports and risk assessments, managed deviations identified during PQ validations, and developed Standard Operating Procedures (SOPs) for the equipment they validated. A crucial element of their role was coordinating the validation efforts with various stakeholders like the production team, C&M, QA, maintenance, and QC, ensuring efficient planning and resource allocation. The validation scope covered essential utilities such as compressed air, water for injection, pure steam, O2, CO2, and N2; clean rooms, including dry-fogging, environmental monitoring for grades C&D, and thermal mapping; and process equipment like autoclaves for sterilization and decontamination, washing machines, manual cleaning processes, and decontamination stations.
ALTEN Technology’s significant contribution to the project, which ran from July 2017 to May 2019 in Wavre, Belgium, with a team of 11 full-time equivalents, was the establishment of a single team to manage end-to-end validation for all new utilities and equipment. Their capability to serve as a central coordination point for diverse teams—including engineering, validation, maintenance, production, and QA—was a key differentiator. This demonstrated ALTEN Technology’s high qualification, flexibility to respond quickly to evolving business priorities, and a robust methodology supported by relevant Key Performance Indicators, effective team management tools, and structured governance meetings.