Stratogene Pharma
batches/live 3/hold
Today
Active
3
Ready
2
Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
Batch: PAR-0124
Product: Paracetamol 500mg Tablets
Packaging: 🟢 Bottle
Requested by: Amit Patel (Production Supervisor)
Requested at: 6/3/2026, 5:15:00 AM
⏸️ HOLD REQUEST
Awaiting QA Manager approval
Time since request: 5d 9h ago
Current Stage: Packing (35% complete)
Checks entered: 3
OOS events: 1 (Fill Weight Check #3)
Batch yield so far: 98% (partial)
Hold Details
Hold Reason Category
OOS Investigation
Estimated Hold Duration
4 hours (as estimated by Amit Patel)
Hold Reason Details
Fill Weight Check #3 returned 486.2 mg (spec: 490-510 mg). Production stopped pending QA investigation. Affected tablets quarantined at Line 3 compression stage.
Impact on Schedule
Batch completion delayed ~4 hours
OOS Event Summary
Parameter: Fill Weight · Value: 486.2 mg · Spec: 490–510 mg
Deviation: -3.8 mg (0.78% below spec minimum) · Check #3 of 5 planned
View OOS Check Details →Batch Status at Time of Hold Request
| # | Parameter | Value | Status | Time |
|---|---|---|---|---|
| #1 | Fill Weight | 501.2 mg | ✅ PASS | 02:45 AM |
| #2 | Fill Weight | 499.8 mg | ✅ PASS | 03:30 AM |
| #3 | Fill Weight | 486.2 mg | 🔴 OOS ← triggered hold | 05:00 AM |
Environmental at time of hold
Temp: 22.8°C ✅ · Humidity: 49% ✅ (both within limits)
Equipment
Compression Machine A · Calibrated: 14 days ago
⚠️ Fill Weight trending downward across 3 checks: 501.2 → 499.8 → 486.2 mg.
Consistent decline suggests equipment drift rather than random variation. Hypothesis: Machine A calibration drift (similar to DEV-MET-0891-002 resolved June 5).
QA Manager Decision
Review the hold request and provide your decision
Hold Risk Assessment
Risk: ✅ LOW — investigation proceeds safely
Hold protects batch quality and maintains GMP compliance.
Schedule Impact
- Estimated delay: ~4 hours
- Downstream batches affected: 1
- Customer delivery impact: Minimal
Similar Past Holds on Machine A
HOLD-MET-0891
June 5, 2026
Reason: Fill Weight OOS (485 mg) · Duration: 2.5 hours
Outcome: ✅ Resolved — Machine A recalibrated. Calibration drift confirmed, corrected, batch released.
HOLD-MET-0843
March 2026
Reason: Fill Weight OOS · Duration: 3 hours
Outcome: ✅ Resolved — CAPA raised and closed.
Insight: Both similar holds were approved and resolved within 3 hours via Machine A recalibration.