Process Optimisation for the Market Launch of an API Product.

As a superior issue the whole project team has been exchanged, the project budget has grown from 5 million EUR to approx. 25 million EUR and a limited batch validation process capacity has been detected. As a major bottlenecks the cleaning validation, including more than 5 percent of OOS batches, was determined. Moreover, streamlined communication management without clear communication paths and lacking transparency was present. Finally, no person in plant was installed to provide a single point of contact and to ensure the correct project coordination.