Water for injection, purified water, clean steam, compressed gases and HVAC all come into contact with product or the environment it is made in. GMP expects these utilities to be monitored against defined alert and action limits, with excursions investigated. EU GMP Annex 1 covers utilities as part of contamination control for sterile products. Spreadsheets make it easy to lose track of which limit applied to which result, and an action breach can sit unnoticed in a log.
From limit to result
In Swat iQua Suite each utility system is registered for the site. Alert and action limits are defined per system type and parameter as versioned records, approved with three-way segregation of duties and an e-signature, with one effective version at a time. Group-wide limits can be shared, and a site can set its own, which take precedence for that site.
When a monitoring result is recorded, the server looks up the effective limit, stores the alert and action values and the limit version on the result, and classifies it. Because the limit is frozen on the result, a later change to the limits never rewrites history: an inspector sees exactly which limit a result was judged against. An action-level result raises a deviation automatically, so investigation starts straight away.
Part of the sterile platform
- Sits alongside Environmental Monitoring for cleanroom EM and gowning.
- Referenced by your contamination control strategy register.
- Deviations follow the normal investigation and CAPA route in the QMS.