Qualification ensures that all systems and processes in pharmaceutical water treatment are properly installed and operated to guarantee the required water quality.
Qualification is a crucial part of the quality management system in pharmaceutical water treatment and refers to the process of determining and documenting that the equipment, facilities, systems, and processes are properly installed, operated, and monitored to ensure the desired quality of the produced water.
Qualification typically includes the following main aspects:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Production Qualification (PQ)