7.3 Continuous system monitoring

After completion of phase 3 of the qualification programme for the WPU system, a system review should be undertaken. Following this review, a routine monitoring plan should be established based on the results of phase 3.

Monitoring should include a combination of online instrument monitoring of parameters such as flow, pressure, temperature, conductivity and total organic carbon, and offline sample testing for physical, chemical and microbiological attributes. Offline samples should be taken from points of use and specific sample points. Samples from points of use should be taken in a similar way to that adopted when the water is being used in service.

Tests should be carried out to ensure that the selected pharmacopoeia specification has been satisfied, and should include, as appropriate, determination of conductivity, pH, heavy metals, nitrates, total organic carbon, total viable count, presence of specific pathogens and endotoxins. Monitoring data should be subject to trend analysis.