Isolators/RABS and Quality Trend Metrics - BCW
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Isolators/RABS and Quality Trend Metrics John Wallingford Operations Director - Pharmagraph PHSS SIG Member
Transcript of Isolators/RABS and Quality Trend Metrics - BCW
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
3
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
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6
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2
1
3
13
4
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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
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
3
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.
12
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
