Task
A pharmaceutical company required the reliable supply of AP water to eight new production areas, adhering to pharmaceutical standards. This involves the construction of four new, nearly identical AP water storage facilities with the corresponding distribution systems, storage tanks, distribution lines, and automation technology. The systems must be fully documented and qualified in accordance with GMP (Good Manufacturing Practice) regulations. The client expects a complete turnkey solution: planning, project coordination, construction, and qualification.
Solution
Lehmann Engineering managed the entire project from planning to commissioning and qualification. A total of 12 system suppliers were involved, the coordination was handled by Lehmann Engineering as well: We acted as the customer vis-à-vis the system suppliers, coordinated interfaces with manufacturers, building technology, and consumers. Furthermore, we conducted the entire qualification process consistently according to DQ, OQ, and PQ. For this purpose, we created and processed all relevant documents, including URS, GxP risk analysis, FAT/SAT plans (Factory Acceptance Test / Side Acceptance Test), and qualification plans. Upon completion, the customer took over the plant ready for production.
Customer benefits
- Everything from a single source – one contact person throughout the entire project
- GMP-compliant supply for eight new production lines
- Uniform system structure for simplified maintenance and operation
- Complete documentation and qualification from a single source
- Efficient supplier coordination and smooth commissioning
