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 the customer’s project qualification team onsite and give full support to its validation activities.
GSK Biologicals turned to NNE Pharmaplan, a company known for its qualification and validation expertise. NNE Pharmaplan coordinated the qualification activities to ensure they met both regulatory requirements and the customer’s needs. The NNE Pharmaplan 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.
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