8. Inspection of water systems

WPU (PW, HPW and WFI) systems are likely to be the subject of regulatory inspection from time to time. Users should consider conducting routine audit and self-inspection of established water systems.

This GMP guidance can be used as the basis of inspection. The following list identifies items and a logical sequence for a WPU system inspection or audit:

- a sampling and monitoring plan with a drawing of all sample points;

- the setting of monitoring alert and action levels;

- monitoring results and evaluation of trends;

- inspection of the last annual system review;

- review of any changes made to the system since the last audit and check that the change control has been implemented;

- review of deviations recorded and their investigation;

- general inspection of system for status and condition;

- review of maintenance, failure and repair logs; and

- checking calibration and standardization of critical instruments.

For an established system that is demonstrably under control, this scope of review should prove adequate. For new systems, or systems that display instability or unreliability, the following should also be reviewed:

- performance qualification;

- operational qualification; and

- installation qualification.