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Risk Assessment

CQA Formulation and Process Variables
EC Level Curing Temp. Curing Time Spray Rate Atomizing
Air Pressure
Inlet Temp.
Drug release at 8hr High High High Low Low Low
Assay Low Low Low Low Low Low
Content Informity Medium Low Low Low Low Low
Apprearence High High High Low Low Medium
Pellets Density High Low Low Low Low Low

Validation Inventory

No of Entities
  • Validated
  • Verified
  • WIP
  • Pending
  • Impacted
  • Inactive
  • N/A
Status

IoT : Clean Room Monitoring

Degree in Fahrenheit
0 10 20 30 40 50 10.00 10.05 10.10 10.15 10.20 10.25 10.30 10.35 10.40 10.45 Threshold - 55℉
Time
CDR Cabinet
Aseptic filling area
Air Handling Area

OQ Execution Summary

Pass
Fail
N/A
Pending