GMP Annex 1: Trending Is Now Mandatory
With the revision of GMP Annex 1 (August 2023), trending of cleanroom data is no longer a recommendation but a binding requirement. Annex 1 explicitly demands regular evaluation and assessment of trends to detect potential deviations early and continuously improve the Contamination Control Strategy (CCS).
The Challenge in Practice
For many companies, implementing this requirement poses a significant challenge. Trend reports must be created regularly, assessed by qualified personnel, and documented in an audit-proof manner. Especially with discontinuous, mobile monitoring, gathering and consolidating data from various measurement locations is extremely time-consuming. In many cases, this is still done manually – with Excel spreadsheets, laborious data exports, and lengthy review cycles. This ties up valuable resources and carries the risk of errors.
The Solution: Trending with Moqlero in Under One Minute
Moqlero makes trending easier than ever before. With just a few clicks, a complete trend report is generated – including graphical and tabular presentation, optional comment, and electronic signature. The entire process takes less than one minute while meeting all regulatory requirements for data integrity (ALCOA++) and 21 CFR Part 11.
6 Specialized Trend Types for Maximum Coverage
Moqlero offers six different trend types covering the relevant parameters of discontinuous cleanroom monitoring:
- Filter Efficiency: Monitors filter retention performance over time to ensure long-term filtration performance can be maintained.
- Filter Differential Pressure: Tracks pressure differences across filters to enable early detection of clogging trends and proactive optimization of filter maintenance.
- Particle Counts: Visualizes the development of particle concentrations over configurable time periods to enable the detection of contamination risks and trends.
- Physical Environment: Trend analysis for environmental parameters such as temperature and humidity to ensure process stability and compliance.
- Air Volume Flow: Displays trends in airflow volumes to verify consistent ventilation rates in cleanroom zones.
- Air Exchange Rate: Analyzes air exchange frequency over time to ensure compliance with cleanroom standards.
Audit-Ready at the Push of a Button
Every trend report is automatically generated as a tamper-proof PDF and cryptographically signed. The integrated comment and assessment function enables seamless documentation of expert evaluations – exactly as required by Annex 1.
With Moqlero, trending transforms from a time-consuming obligation into a routine standard task – fast, secure, and fully GMP-compliant.