batches/live 2/closure
Audit
IBU-0340
Ibuprofen 200mg Tablets
STRIP
Manufacturing: 6/2/2026 – 6/4/2026
Closure Readiness Score
100/100
✅ READY TO CLOSE
Batch Size: 20 kg
Actual Yield: 19.2 kg
Yield %: 96% ✅
Time in Production: 2 days

Pre-Closure Verification Checklist

All items must be ✅ before batch can be closed.

🔷Quality Checks
7/7 complete
All Compression checks entered
14 checks entered | 14 PASS | 0 OOS
All Compression checks within spec
Fill Weight avg 500.3 mg ✓ | Hardness avg 9.4 kP ✓
All Coating checks entered
4 checks entered | 4 PASS | 0 OOS
All Coating checks within spec
Weight Gain avg 4.1% ✓ | Pan Temp avg 50.2°C ✓
All Packing checks entered
8 checks entered | 8 PASS | 0 OOS
All Packing checks within spec
Tablet Count 10 ✓ | Seal Integrity intact ✓
Metal Detector CCP validated
3/3 challenge tests PASS (ferrous, non-ferrous, stainless)
🏭Manufacturing Checks
5/5 complete
Yield within acceptable range
96.0% (19.2 kg / 20 kg theoretical) | Target: 95-102%
Yield reconciliation complete
Waste: 0.8 kg (4.0%) — within acceptable loss limit
All line clearances documented
3 clearances performed | All dual-signed
All shift handovers complete
2 handovers recorded | All dual-signed
No unresolved batch holds
0 holds recorded during production
🧪Quality Assurance Checks
4/4 complete
All deviations resolved
0 deviations recorded | 0 open | 0 pending
All CAPA actions completed
0 CAPAs linked to this batch
Environmental monitoring complete
12 readings taken | All within limits. Temp 21.8–22.4°C ✓ | Humidity 44–52% ✓
OOS rate acceptable
0 OOS events (0% OOS rate) | Fleet benchmark: 1.14%
📋Documentation & Compliance
5/5 complete
Audit trail complete
89 entries | No gaps detected | All timestamped. Integrity: SHA-256 verified
All operator signatures present
14 check entries signed | 3 line clearances signed | 2 shift handovers signed
Equipment calibration current
Machine A: calibrated June 5 ✓ | Strip Packer: calibrated July 3 (valid) ✓
21 CFR Part 11 controls active
E-signatures ✓ | Data integrity ✓ | Audit trail ✓ | Time sync ✓
Data retention configured
3-year retention from batch expiry. Expiry: June 2026 | Retain until: June 2029
Total items: 21✅ 21🔴 0🟠 0
IBU-0340 Performance
Quality Score100/100 ✅
Yield96% ✅
OOS Rate00.00% ✅
Cycle Time2 days ✅
Deviations0 ✅
vs Fleet Average
Quality Score100 vs 87 avg ✅
Yield96% vs 97.2% avg 🟠
OOS Ratevs 1.14% avg ✅
vs Golden Batch (MET-0889)
Fill / Weight avgIn spec ✅
Yield96% vs 96.5% 🟠
OOS Rate0% vs 0% ✅
Deviations0 vs 0 ✅
✅ Matches Golden Standards
Production Timeline
June 2
Batch initiated (Amit Patel)
June 2
Compression started — 8 checks | 0 OOS
June 3
Coating started — 4 checks | 0 OOS
June 4
Packing started — 8 checks | 0 OOS
June 4
Packing complete
June 5
Ready for closure
Today
Closure review
💡 Recommended Disposition
✅ RELEASE
Confidence: HIGH (100/100 score)
Basis:
  • ✅ All checks status
  • ✅ Deviations
  • ✅ CAPA actions
  • ✅ Yield 96%
  • ✅ Full audit trail
  • ✅ 21 CFR Part 11 compliant
Risk Level: ✅ LOW
eBR Preview
Batch Record: IBU-0340 · Ibuprofen 200mg Tablets
Batch Size: 20 kg · ~12 pages (estimated)
Will include:
  • ✅ All check results
  • ✅ Environmental records (12 readings)
  • ✅ Line clearances (3)
  • ✅ Shift handovers (2)
  • ✅ E-signature manifest
  • ✅ Audit trail (last 50 entries)
  • ✅ SHA-256 hash (tamper-proof)
Preview eBR
Back to Batches
Reviewing as Rajesh Kumar