Active Batches
12
across 3 lines
Completed Today
8
+2 vs yesterday
Yield Rate
98.7%
+0.3% MTD
Quality Holds
2
1 pending review
Avg Cycle Time
4.2h
-0.3h vs target
Right First Time
96.1%
above 95% target
Deviations
1
minor severity
Equipment OEE
91.3%
+1.2% WoW
Active Batch Progress
PB-2026-0471Active
Amoxicillin 500mg Capsules
Compression
72%
PB-2026-0470Active
Metformin HCl 850mg Tablets
Coating
88%
PB-2026-0468Hold
Omeprazole 20mg DR Capsules
Granulation
45% — HOLD
PB-2026-0467Active
Atorvastatin Calcium 40mg Tablets
Weighing & Dispensing
18%
Recent Events
14:32Batch PB-2026-0469 released to packaging — QA approved
14:18Quality hold placed on PB-2026-0468 — moisture content OOS
13:55PB-2026-0471 entered compression stage — Tablet Press TP-04
13:41In-process weight check PASS for PB-2026-0470
13:22Operator shift change — M. Chen to S. Patel on Line 2
12:58Environmental monitoring — Clean Room B passed particle count
12:35Deviation DEV-2026-041 opened — granule size distribution
12:10PB-2026-0467 initiated — raw material dispensing started
| Batch ID | Product Name | Recipe | Stage | Progress | Status | Start Time | Operator |
|---|
Batch Genealogy
Process Parameters
Batch Notes
Tests Today
47
Pass Rate
97.9%
Open Deviations
1
Pending Reviews
3
| Test ID | Batch | Parameter | Spec Range | Result | Status |
|---|
Deviation Report
GMP Compliance Checklist
- Environmental monitoring records reviewed
- Equipment calibration certificates current
- Raw material Certificates of Analysis verified
- Operator training records confirmed up-to-date
- In-process controls within specification limits
- Electronic batch record completeness verified
- Line clearance procedures completed
- Water system qualification results within limits
- Deviation log reviewed and cleared
- CAPA actions completed and effectiveness verified
- Cleaning validation records current
- QA final release authorization signed
Electronic Signature
21 CFR Part 11 Compliant Signature
Audit Trail
| Timestamp | User | Action | Details |
|---|---|---|---|
| 2026-04-03 14:32:18 | S. Mitchell | BATCH_RELEASE | PB-2026-0469 released to packaging |
| 2026-04-03 14:18:05 | R. Nakamura | QUALITY_HOLD | PB-2026-0468 placed on hold — OOS moisture |
| 2026-04-03 13:55:42 | SYSTEM | STAGE_CHANGE | PB-2026-0471 entered Compression |
| 2026-04-03 13:41:19 | M. Chen | IPC_PASS | Weight uniformity check — within spec |
| 2026-04-03 13:22:33 | SYSTEM | SHIFT_CHANGE | Operator handoff Line 2: M. Chen to S. Patel |
| 2026-04-03 12:58:11 | J. Kim | ENV_MONITOR | Clean Room B particle count — PASS |
| 2026-04-03 12:35:47 | R. Nakamura | DEVIATION_OPEN | DEV-2026-041 opened — granule size OOS |
| 2026-04-03 12:10:02 | S. Patel | BATCH_INIT | PB-2026-0467 initiated — dispensing |