GxP Biotech warehouse expansion and transition
The challenge
While building a new factory, a leading bio-tech manufacturer (CAR-T cell therapy for cancer treatment), the internal warehouse needed expand, storage capacity to increase and the material flows needed to be further professionalized to enable future growth. Remain operating in a GxP compliant environment, with ongoing construction activities showed to be very challenging.
The Approach
Together with the construction project team, the logistics team and in close collaboration with Quality Assurance and Quality Engineering, LOGIBILITY planned a phased approach for aligning ongoing GxP warehouse operations with the construction activities, coordinated the installation and qualification of all warehouse equipment and functionally designed and implemented Oracle WMS as the leading system to manage the warehouse processes.
In addition, LOGIBILITY contributed to continuous warehouse process improvements and trained the WMS key-user on the relevant key-user activities.
The Result
A successful expansion of the GxP compliant warehouse to support the cleanroom production, double in size, including expanded qualified temperature-controlled storage (cold rooms, refrigerators and freezers) and including WMS supported warehouse operations to enable full product traceability.
The GxP compliant warehouse operations and material flows continued at all times during the entire transition.
