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Rajesh Kumar
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Stratogene Pharma
deviations
/
dev ibu 0301 001
Today
Active
3
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Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
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DEV-IBU-0301-001
Closed
Batch
IBU-0301
· Fill Weight OOS — Machine A
Phase I — Initial assessment
Root cause hypothesis
Lab testing required
Investigation notes
Save Phase I
Phase II — Root cause analysis & CAPA
Confirmed root cause
Raw material particle size variation (incoming lot)
Corrective action
Released new API lot; reworked batch.
Preventive action
Added incoming particle-size screen.
Save Phase II
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