All direct impact utilities (affecting product quality) have to be:
- properly designed
- carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products
- adequately monitored
The direct impact utilities are:
- clean rooms and HVAC
- purified water
- water for injection
- pure steam
- compressed air and nitrogen
The qualification of utilities starts from risk analysis. Based on the risk analysis, a qualification strategy and required tests are selected.
The qualification should include the following documentation:
- Design qualification (DQ) is a documented verification that the proposed design of the facilities, systems, and equipment is suitable for the intended purpose.
- Installation qualification (IQ) is a documented verification that the facilities, systems, and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
- Operational qualification (OQ) is a documented verification that the facilities, systems, and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
- Performance qualification (PQ) is a documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.
The operational and performance qualification provides information on deviations that might occur. Within the qualification, we assess how these deviations can affect utility performance. Based on the risk analysis, we rank the deviations to critical, major, minor and give recommendations on required corrective actions. These recommendations are the basis for developing a deviation SOP for each system.
Based on the data obtained during the qualification and risk analysis, we provide recommendations on monitoring. Recommendations include:
- sampling points
- sampling frequency
- quality control method
- statistically-based alarm level