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Rajesh Kumar
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Stratogene Pharma
deviations
/
dev met 0801 001
Today
Active
3
Ready
2
Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
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3
DEV-MET-0801-001
Closed
Batch
MET-0801
· 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
Machine speed setting drift (turret RPM low)
Corrective action
Recalibrated turret speed; retested 30 tablets.
Preventive action
Added speed verification to changeover checklist.
Save Phase II
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