Environmental Monitoring System

The environmental monitoring system is the qualified record of conditions in classified areas — non-viable particle counts, differential pressure, temperature and humidity — recorded continuously and alarmed on excursion. Its independence from the system that does the controlling is the point of it: a record produced by the same system that maintains the condition cannot be evidence about that condition.

Because it is the GMP record, it carries the obligations of one. Alarms have to reach someone able to act within a time that matters, excursions have to reach an assessment rather than an acknowledgement, and the data has to be secure, attributable and retained. An EMS whose alarms are routinely acknowledged at the panel and never assessed is producing a complete record of unexamined events.

Sensor placement is where its value is decided. A probe positioned for cabling convenience rather than at the point of risk records a condition nobody needed to know, and does so faithfully for years — which is why placement rationale belongs in the qualification package alongside the sensor calibration.

• —The independent, qualified record of classified-area conditions.
• —Independence from the controlling system is what makes it evidence.
• —Alarms must reach someone able to act; excursions must reach an assessment, not an acknowledgement.
• —Sensor placement rationale belongs in the qualification package.
• —A conveniently placed probe records the wrong location faithfully for years.

EU GMP Annex 1 (2022) for continuous viable and non-viable monitoring of Grade A/B areas; ISO 14644-2 for monitoring; EU GMP Annex 11 for the computerised system.