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Rajesh Kumar
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Stratogene Pharma
deviations
/
dev met 0843 001
Today
Active
3
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Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
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DEV-MET-0843-001
Closed
Batch
MET-0843
· 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
Calibration drift on load cell
Corrective action
Recalibrated Machine A; verified with reference weights.
Preventive action
Tightened calibration interval to 14 days.
Save Phase II
Close deviation