Formulation equipment recombinant blood coagulation factor 8
Partner: CARPUS+Partner AG (for BAYER AG)
Project duration: March 2017-April 2018
Project Scope: Detail Engineering support, Installation and Commissioning for Formulation Equipment for recombinant factor 8 in a tech transfer project from the US to Germany
IMPROCESS services included
– Lead of engineers (customer, supplier)
– Ensured GMP compliant (DQ) installation by supplier
– Supervision of installation to ensure correct, error-free and GMP compliant installation by supplier
– Technical check (GMP) of supplier documentation
– Claims Management
– Contract Management
– Single-Point of Contact for Process Owner for Formulation work package
– Commissioning support
– Change Control for technical changes
– Deviation Management
Our support services and our expertise enabled our customer to successfully complete the project.
Voice of the Customer
IMPROCESS GmbH services allowed us to hand over a GMP compliant equipment according to DQ requirements. In this highly regulated and complex Biopharma environment IMPROCESS showed us the path to success. Despite the challenging project environment we had a lot of fun working with IMPROCESS consultants. We will be very happy to join forces with IMPROCESS highly qualified, reliable and trustworthy consultants in future projects.
Dipl. Ing. Jochen Schumacher, Head of Process Planning Carpus+Partner AG, Aachen
IMPROCESS showed us how to reach our project goals faster and more successfull in a highly regulated and complicated project environment.
Sönke Morgenstern, Partner / Prokurist, Head of Technology + Process CARPUS+Partner AG, Aachen