Active Deviations
DEV-024 · BT-2406-044
Pantoprazole 40mg · IPQC Stage
Open
⚠ Tablet hardness 6.2 kP exceeds limit of 5.5 kP max
Root Cause
Compression force too high — operator error
CAPA Action
Reduce to 8 kN · Re-validate 10 tablets
CAPA Progress
Deviation documented & reviewed
QA Manager · 02 Jun 2026
Root cause investigation complete
Production Head · 03 Jun 2026
CAPA implementation in progress
Due: 08 Jun 2026
Effectiveness verification
Pending
QA closure sign-off
Pending
DEV-023 · BT-2406-040
Amoxicillin 500mg · Dispensing Stage
Under Review
⚠ API weight variance 2.3% over approved RMC quantity
Root Cause
Weighing balance calibration drift
CAPA Action
Calibrate all balances · Monthly SOP
CAPA Progress
Deviation documented & reviewed
QA Manager · 01 Jun 2026
Root cause investigation in progress
Due: 05 Jun 2026
Effectiveness verification
Raise New Deviation
Closed Deviations
| Dev. | Batch | Description | Closed | COA |
|---|
| DEV-022 | BT-2405-038 | Moisture 2.4% vs 2.0% limit | 25 May | |
| DEV-021 | BT-2405-036 | Fill weight ±7 mg vs ±5 mg | 18 May | |