enVigil-FMSPHSS SIG Member
Isolators and RABS Systems • EU-GMP Annex 1 is proposing more use
of Isolator and
RABS for integrated filling lines.
• Integrated Isolators for Small Batch Production will be the way
forward for new drug production facilities
• Small Batch Isolators require Integrated Monitoring Systems for
non-viable and viable particle counts
Typical Sampling Positions from Risk Assessment
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Small Batch Isolator System
Quality Trend Metrics FDA are introducing a Quality Metrics
Reporting Program
Quality Trend information applicable to all areas of the Drug
Supply chain
Reinforces Quality Risk Management
Quality Metrics guidance being issued for the Industry
The aim is for continuous improvement in Quality driven by both FDA
and MHRA
Aseptic Processing is the Main Drug Shortage Challenge
Quality related issues are biggest factor in Drug
shortages
Quality Trend Metrics • What does this mean to the
Pharmaceutical
Production Facility
• Where does the environmental monitoring system logged data fit in
with the Quality Trend Metrics requirements
• Alarms (Actions) and Warnings(Alerts) are directly applicable to
Batch/Lot release – Aseptic Filling Lines which stop production
upon an
Alarm transition will affect Lot (Batch) Acceptance Rate .
– Alarm reports for storage facilities (cold chain storage) and
Mean Kinetic Temperature reports for storage facilities
(warehouses) will support Stability Testing results for Product
Stability over time.
Quality Trend Metrics
Alerts Alarms System Errors
Environmental Monitoring Systems are being enhanced with a Trend
Metrics option:- Allowing alert and alarm information to be trended
by hour/day, day/month and month/year across critical process
parameters such as:-
Particle counts Differential Pressure Temperature Humidity
Quality Trend Metric Reports are provided from
EMS System Alarm reports.
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3
2
8
6
2
2
1
3
13
4
9
Sheet1
Alerts
Alarms
Quality Trend Metrics
Production Group Trend Metric Reports provide a visual display of
where Quality Issues are present
Will allow Production Supervisors and QC personnel to determine the
number of alerts and alarms that are generated over a specific user
configured time period:-
Hour by Day Day by Month Month by Year
Quality Trend Metrics
This information will support quality data which will correlate to
the quality of the finished product and allow analysis of the
facility/ personnel performance
Selected by room, zone or equipment allowing detailed reports to be
produced.
“Medal Table” shows most frequent failures which can then help with
rectification of problems:- personnel training, equipment failure,
manual interventions etc. etc.
Dianummer 1
Small Batch Isolator System