Stratogene Pharma
batches/live 2/ebr
Today
Active
3
Ready
2
Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
STRATOGENE PHARMA
Pvt. Ltd.
ELECTRONIC BATCH RECORD
- Product:
- Ibuprofen 200mg Tablets
- Batch Number:
- IBU-0340
- Batch Size:
- 20 kg (approx. 200,000 tablets)
- Manufacturing:
- 02 Jun 2026 — 04 Jun 2026
- Packaging Type:
- STRIP (Primary)
- Manufactured by:
- Stratogene Pharma Pvt. Ltd.
Plot 14, Pharma SEZ, Bengaluru, Karnataka 560099 - QA Released by:
- Rajesh Kumar, QA Manager
- Release Date:
- 05 Jun 2026
- Document ID:
- eBR-IBU-0340-2026
- System:
- QsutraIPQA v1.0
✓ RELEASED — Approved for Distribution
Batch Summary
1. Product Information
- Product Name:
- Ibuprofen 200mg Tablets
- Product Code:
- IBU-200-T
- Batch Number:
- IBU-0340
- Manufacturing Line:
- Line 2
- Batch Size:
- 20 kg theoretical
2. Manufacturing Timeline
- Batch Initiated:
- 02 Jun 2026 08:00:00 IST Day Shift(2026-06-02 02:30:00 UTC)
- Stage 1: Compression:
- 02 Jun 2026 08:30:00 IST Day Shift → 14:00:00 IST Evening ShiftDuration: 5.5 hours(2026-06-02 03:00:00 UTC → 2026-06-02 08:30:00 UTC)
- Stage 2: Coating:
- 02 Jun 2026 14:30:00 IST Evening Shift→ 03 Jun 2026 08:00:00 IST Day ShiftDuration: 17.5 hours (crosses midnight IST)(2026-06-02 09:00:00 UTC → 2026-06-03 02:30:00 UTC)
- Stage 3: Packing (STRIP):
- 04 Jun 2026 08:30:00 IST Day Shift → 17:00:00 IST Evening ShiftDuration: 8.5 hours(2026-06-04 03:00:00 UTC → 2026-06-04 11:30:00 UTC)
- Batch Closed (QA Release):
- 05 Jun 2026 14:32:00 IST Evening Shift(2026-06-05 09:02:00 UTC)
3. Yield Summary
- Theoretical Yield:
- 20.00 kg
- Actual Yield:
- 19.20 kg
- Yield %:
- 96.0% ✓ (Target: 95–102%)
- Losses:
- 0.80 kg (4.0%) — within acceptable limits
4. Quality Summary
- Total IPQA Checks:
- 20
- Checks PASS:
- 20 (100%)
- OOS Events:
- 0
- Deviations:
- 0
- CAPAs:
- 0
5. Disposition
- Status:
- ✓ RELEASED
- Released by:
- Rajesh Kumar (QA Manager)
- Release Date:
- 05 Jun 2026 14:32:00 IST(2026-06-05 09:02:00 UTC)
Stage 1: Compression — IPQA Check Results
- Equipment:
- Compression Machine A (Line 2)
- Operator:
- Priya Sharma (QA Operator — Compression)
- Checks Performed:
- 8 | Pass: 8 | OOS: 0
| Check # | Time | Fill Wt (mg) | Hardness (kP) | Friability (%) | Thickness (mm) | Status |
|---|---|---|---|---|---|---|
| #1 | 08:30 IST | 201.2 | 9.4 | 0.6 | 4.2 | ✓ PASS |
| #2 | 09:15 IST | 200.8 | 9.2 | 0.7 | 4.1 | ✓ PASS |
| #3 | 10:00 IST | 201.5 | 9.5 | 0.6 | 4.2 | ✓ PASS |
| #4 | 10:45 IST | 200.3 | 9.3 | 0.7 | 4.1 | ✓ PASS |
| #5 | 11:30 IST | 201.1 | 9.4 | 0.6 | 4.2 | ✓ PASS |
| #6 | 13:00 IST | 200.9 | 9.2 | 0.6 | 4.1 | ✓ PASS |
| #7 | 13:45 IST | 201.3 | 9.5 | 0.7 | 4.2 | ✓ PASS |
| #8 | 14:00 IST | 200.7 | 9.3 | 0.6 | 4.1 | ✓ PASS |
Specification Ranges: Fill Weight 195–205 mg | Hardness 8–12 kP | Friability <1% | Thickness 4.0–4.4 mm
Stage Cpk (Fill Weight): 1.72
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
Stage Cpk (Fill Weight): 1.72
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
Stage 2: Coating — IPQA Check Results
- Equipment:
- Coating Pan — Line 2
- Operator:
- Rohan Mehta (QA Operator — Coating)
- Checks Performed:
- 4 | Pass: 4 | OOS: 0
| Check # | Time | Weight Gain (%) | Pan Temp (°C) | Pan Speed (RPM) | Status |
|---|---|---|---|---|---|
| #1 | 15:00 IST | 4.1 | 50.2 | 25 | ✓ PASS |
| #2 | 17:00 IST | 4.2 | 50.4 | 25 | ✓ PASS |
| #3 | 19:00 IST | 4.1 | 50.1 | 25 | ✓ PASS |
| #4 | 21:00 IST | 4.2 | 50.3 | 25 | ✓ PASS |
Specification: Weight Gain 3.5–4.5% | Pan Temp 48–52°C | Pan Speed 20–30 RPM
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
Stage 3: Packing (STRIP)
- Equipment:
- Strip Packing Machine — Line 2
- Operator:
- Sanjay Khanna (QA Operator — Packing)
- Checks Performed:
- 8 | Pass: 8 | OOS: 0
| Check # | Time | Tablet Count | Seal | Print Quality | Status |
|---|---|---|---|---|---|
| #1 | 09:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #2 | 10:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #3 | 11:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #4 | 12:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #5 | 13:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #6 | 14:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #7 | 15:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
| #8 | 16:00 IST | 10 ✓ | Intact ✓ | Legible ✓ | ✓ PASS |
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
Critical Control Point: Metal Detector Validation
- Equipment:
- Metal Detector — Line 2
- Validation Date:
- 04 Jun 2026
- Validated by:
- Sanjay Khanna
Challenge Test Results
| Test | Test Piece | Result | Status |
|---|---|---|---|
| 1 | Ferrous (1.5 mm) | DETECT | ✓ PASS |
| 2 | Non-Ferrous (2.0 mm) | DETECT | ✓ PASS |
| 3 | Stainless (2.5 mm) | DETECT | ✓ PASS |
CCP Status: ✓ VALIDATED — All challenge tests passed
Sensitivity: Set to 1.5 mm ferrous equivalent
Next Validation Due: Next batch
Sensitivity: Set to 1.5 mm ferrous equivalent
Next Validation Due: Next batch
Environmental Monitoring Log
- Monitoring Period:
- 02 Jun 2026 — 04 Jun 2026
- Total Readings:
- 12
| Date/Time | Location | Temp (°C) | Humidity (%) | Pressure (Pa) | Status |
|---|---|---|---|---|---|
| 02 Jun 08:00 | Compression | 22.1 | 46 | +12 | ✓ |
| 02 Jun 14:00 | Compression | 22.3 | 48 | +11 | ✓ |
| 02 Jun 20:00 | Compression | 22 | 47 | +12 | ✓ |
| 03 Jun 08:00 | Coating | 22.4 | 49 | +11 | ✓ |
| 03 Jun 14:00 | Coating | 22.2 | 48 | +12 | ✓ |
| 03 Jun 20:00 | Coating | 22.1 | 47 | +11 | ✓ |
| 04 Jun 08:00 | Packing | 22.3 | 46 | +12 | ✓ |
| 04 Jun 11:00 | Packing | 22.5 | 48 | +11 | ✓ |
| 04 Jun 14:00 | Packing | 22.4 | 49 | +12 | ✓ |
| 04 Jun 17:00 | Packing | 22.2 | 47 | +11 | ✓ |
| 04 Jun 20:00 | Packing | 22.1 | 46 | +12 | ✓ |
| 05 Jun 08:00 | QC Lab | 22 | 45 | +11 | ✓ |
Acceptable Ranges: Temp 19–25°C | Humidity 35–55% | Pressure > +10 Pa
✓ All readings within acceptable limits
✓ All readings within acceptable limits
Line Clearance Log
Total Line Clearances: 3
Clearance 1 — Before Compression
- Date/Time:
- 02 Jun 2026, 07:45 IST Day Shift(2026-06-02 02:15:00 UTC)
- Cleared by:
- Priya Sharma (QA Operator)
- Verified by:
- Rajesh Kumar (QA Manager)
- Status:
- ✓ CLEARED
Clearance 2 — Before Coating
- Date/Time:
- 02 Jun 2026, 14:30 IST Evening Shift(2026-06-02 09:00:00 UTC)
- Cleared by:
- Rohan Mehta (QA Operator)
- Verified by:
- Rajesh Kumar (QA Manager)
- Status:
- ✓ CLEARED
Clearance 3 — Before Packing
- Date/Time:
- 04 Jun 2026, 07:45 IST Day Shift(2026-06-04 02:15:00 UTC)
- Cleared by:
- Sanjay Khanna (QA Operator)
- Verified by:
- Rajesh Kumar (QA Manager)
- Status:
- ✓ CLEARED
Shift Handover Log
Total Handovers: 2
Handover 1 — End of Day Shift — 02 Jun 2026
- Date/Time:
- 02 Jun 2026, 14:00 IST Evening Shift(2026-06-02 08:30:00 UTC)
- From:
- Priya Sharma
- To:
- Rohan Mehta
- Batch Status at Handover:
- Compression 60% complete
- Open Issues:
- None
- Signed by:
- Priya Sharma + Rohan Mehta ✓
Handover 2 — End of Evening Shift — 03 Jun 2026
- Date/Time:
- 03 Jun 2026, 19:30 IST Evening Shift(2026-06-03 14:00:00 UTC)
- From:
- Rohan Mehta
- To:
- Sanjay Khanna
- Batch Status at Handover:
- Coating complete. Packing ready.
- Open Issues:
- None
- Signed by:
- Rohan Mehta + Sanjay Khanna ✓
Deviations Log
- Total Deviations:
- 0
- OOS Events:
- 0
Status: ✓ NO DEVIATIONS RECORDED
This batch was manufactured without any deviations from specifications or standard operating procedures.
This batch was manufactured without any deviations from specifications or standard operating procedures.
CAPA Summary
- Total CAPAs:
- 0
Status: ✓ NO CAPAs REQUIRED
Yield Reconciliation
Input Material
- Raw Material Input:
- 20.00 kg
- Granulation Weight:
- 19.80 kg
Output Breakdown
| Component | Weight (kg) | % |
|---|---|---|
| Finished Product | 19.20 | 96.0% |
| Rejected Tablets | 0.00 | 0.0% |
| In-Process Samples | 0.20 | 1.0% |
| Line Waste | 0.30 | 1.5% |
| Retained Samples | 0.10 | 0.5% |
| Unaccounted | 0.20 | 1.0% |
| Total Output | 20.00 | 100.0% |
Yield: 96.0% ✓ Within acceptable limits (95–102%)
Reconciliation certified by: Amit Patel (Production Supervisor)
Certification Date: 05 Jun 2026
Reconciliation certified by: Amit Patel (Production Supervisor)
Certification Date: 05 Jun 2026
Electronic Signature Manifest
(21 CFR Part 11 Compliant)
🔐 RECORD INTEGRITY
⏳ Computing SHA-256…
Signature 1 — Batch Closure Authorization
- Signed by:
- Rajesh Kumar
- Role:
- QA Manager
- Department:
- Quality Assurance
- Action:
- Batch IBU-0340 approved for release
- Method:
- USERNAME + PASSWORD (Two-component, 21 CFR §11.200)
- Session:
- First signing (full components)
- Signed (UTC):
- 2026-06-05 09:02:00 UTC
- Facility (IST):
- 05 Jun 2026 14:32:00 IST
- NTP Source:
- pool.ntp.org (±47ms)
- UTC Offset:
- +05:30 (Asia/Kolkata)
- Meaning:
- "I certify this batch meets all release criteria per 21 CFR §211.188 and Schedule M."
Signature 2 — Independent Release Verification
- Signed by:
- Rajesh Kumar
- Role:
- QA Manager
- Department:
- Quality Assurance
- Action:
- Independent verification — Batch IBU-0340
- Method:
- USERNAME + PASSWORD (Two-component, 21 CFR §11.200)
- Session:
- First signing (full components)
- Signed (UTC):
- 2026-06-05 09:02:00 UTC
- Facility (IST):
- 05 Jun 2026 14:32:00 IST
- NTP Source:
- pool.ntp.org (±52ms)
- UTC Offset:
- +05:30 (Asia/Kolkata)
- Meaning:
- "I independently verify this batch release decision and confirm the batch record is complete and accurate."
Audit Trail Summary (Last 8 Entries)
| Timestamp | User | Action |
|---|---|---|
| 05 Jun 2026 14:32:47 UTC | Rajesh Kumar | Batch IBU-0340 closed and released |
| 05 Jun 2026 14:32:00 UTC | Rajesh Kumar | E-signature applied to closure |
| 05 Jun 2026 14:30:00 UTC | Rajesh Kumar | Closure checklist completed |
| 05 Jun 2026 10:00:00 UTC | Amit Patel | Yield reconciliation submitted |
| 04 Jun 2026 16:00:00 UTC | Sanjay Khanna | Packing check #8 entered (PASS) |
| 04 Jun 2026 08:30:00 UTC | Sanjay Khanna | Line clearance (Packing) signed |
| 02 Jun 2026 15:00:00 UTC | Rohan Mehta | Coating stage started |
| 02 Jun 2026 08:00:00 UTC | Amit Patel | Batch IBU-0340 initiated |