Rentschler Biotechnologie needed to expand its existing manufacturing capacity with several production lines for biotechnological products. And it had to have consistent qualification documents in all areas to ensure the facility passed inspection. NNE took charge of qualification coordination to help ensure success.
When expanding a facility, it is essential that the manufacturer has consistent qualification documents throughout all areas. Rentschler Biotechnologie faced this problem when adding several production lines to its biotechnological production facility in Laupheim, Germany. In a project coordinated by NNE, communication between all relevant parties proved the key.
Good initial planning leads to smooth process. In such a complex project, good coordination right from the start is the only way to guarantee a successful outcome. NNE started the project with a kick-off meeting involving all relevant client departments.
At the meeting, the qualification concept was presented, and the participants agreed on it. This meant that all expectations and deliverables were clear from the beginning, including project milestones, the timeframe and quality. Frame documents keep suppliers on the right page, and NNE developed the risk analyses based on the agreed concept.
Frame documents were then designed, and these then formed the basis for all qualification activities, helping coordination with suppliers, and maintaining consistency and high quality in all qualification documents. Rentschler Biotechnologie’s head of qualification and validation says, “The qualification concept from NNE helped to keep the traceability and the deviation handling of the whole qualification, while linking back to the risk analyses. The approach of NNE saved us time and resources. We could trust that work was reliable and met deadlines throughout the project.”
The qualification concept from NNE helped to keep the traceability and the deviation handling of the whole qualification, while linking back to the risk analyses. The approach of NNE saved us time and resources.