When GlaxoSmithKline Biologicals needed to build a new vaccine production facility, it turned to NNE for qualification and validation support. The facility was finished on schedule and in time to meet seasonal production demands.
GlaxoSmithKline Biologicals (GSK Biologicals) needed to increase vaccine production at its site in Dresden, Germany, so the company chose to build a new production facility. For qualification and validation, GSK Biologicals wanted a partner that could coordinate its project qualification team on-site and provide full support to its validation activities.
GSK Biologicals turned to NNE, known for its qualification and validation expertise. NNE coordinated the qualification activities to ensure they met both regulatory requirements and the customer’s needs. The NNE team also supported the validation process, controlling and approving validation reports and protocols as well as change control activities.
Ready in time for seasonal production
As an added challenge, the project was executed as a fast-track project, which meant coordinating an international validation team consisting of five separate parties. And, because GSK Biologicals produces vaccines for the seasonal vaccine campaigns, the schedule had to be kept.
Jan. 2006 – Jan. 2009
Coordination of qualification activities, validation support