With the last release of EU GMP Annex 1, a review of practices is often required to ensure that the installed monitoring system complies with Annex 1 requirements. This paper covers:
- Cleanroom Classification
- Pharmaceutical Cleanroom Utilization
- Critical Areas
- Supporting Clean Areas
- Contamination Control Strategy (CCS)
- what should be considered
- Environmental Monitoring Requirements
- Typical automated continuous monitoring system
- Particle Counting
- Microbial Monitoring
- Alarm Beacons
- Central Software
- Data and information displays
- User and area segregation
- Report generator
- Alarms
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