Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

Challenge

Overcoming coordination & timeline challenges

The project faced several challenges that required meticulous coordination and execution. The construction, procurement, validation, and production departments had to align their priorities with strict timelines to ensure the seamless launch of the new production line.

Additionally, the client had limited resources for the final review and approval stages, making efficient and clear communication essential to avoid delays.

Furthermore, over 100 pieces of small-scale equipment, divided into four work packages, needed thorough qualification within a tight timeline. This was crucial for supporting timely process validation runs and ensuring the production line was ready and compliant with regulatory standards.

Approach

Risk-based approach & streamlined project management

To address the challenges, a risk-based approach was used to create and execute the qualification documentation within the limited timeframe. This ensured that all critical aspects were prioritized and managed effectively.

The team focused on quality-driven continuous improvement to establish a more robust framework for operations.

Additionally, the QbD Group team took on overall project planning and follow-up, streamlining processes and enhancing efficiency throughout the project.

Result

Equipment qualification & continuous support

The required equipment was qualified and implemented on schedule, allowing the production department to start process validation runs as planned.

In addition, part of the project team continued to support the client even after the project’s official closure.