Task
As part of its plant expansion and the construction of eight (8) new production facilities, a pharmaceutical company commissioned Lehmann Engineering with the project coordination and qualification of eleven (11) new AP generators. The aim was to expand the AP water supply for the planned production expansion and to ensure GMP-compliant documentation, manufacturing, and commissioning.
Solution
To ensure smooth project development up to commissioning, we created a specification document with an associated GMP risk analysis, a qualification plan, supplier coordination and review of the technical documentation.
We conducted the qualification in accordance with DQ, IQ, OQ, and PQ. We prepared all relevant documents, including URS, GxP risk analyses, FAT/SAT plans, and qualification plans. Our team represented the customer’s interests vis-à-vis the system suppliers, coordinated all interfaces with producers and consumers, and managed the entire implementation based on the qualification process. We planned staggered manufacturing, setup, and qualification. This enabled the customer to commission all eleven (11) AP producers ahead of schedule.
Customer benefits
- 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
- Early commissioning using staggered production and qualification
