Stratogene Pharma
batches/liq par l 0011/ebr
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Active
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Ready
3
Open Dev.
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Yield 30d
95.3%
OOS 30d
0.09%
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
STRATOGENE PHARMA
Pvt. Ltd.
ELECTRONIC BATCH RECORD
Paracetamol Oral Suspension 250mg/5mL
Batch No: PAR-L-0011
Format: Liquid — Oral Suspension | HDPE Bottle 100mL
- Concentration:
- 250mg per 5mL
- Container:
- HDPE Bottle 100mL
- Facility:
- Stratogene Pharma Pvt. Ltd.
Plot 14, Pharmaceutical SEZ, Bengaluru 560099, Karnataka - Line:
- Line 5 — Liquid Manufacturing Suite
- Batch Size:
- 5,000 bottles
- Batch Form Ref:
- BF-PAR-2026-0011
- Water System:
- PW-2026-06-03
- QA Released by:
- Rajesh Kumar, QA Manager
- Release Date:
- 05 Jun 2026
- Standard:
- Schedule M (Revised 2023)
21 CFR Parts 210 & 211
EU GMP Volume 4 - Document ID:
- eBR-PAR-L-0011-2026
✅ RELEASED
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 2 · Batch Formula & Manufacturing Overview
Batch Formula
Reference: BF-PAR-2026-0011
| Ingredient | Quantity per batch |
|---|---|
| Paracetamol API | 250.0 mg per 5mL dose |
| Sucrose | 25.0 %w/v |
| Methyl Paraben | 0.1 %w/v (preservative) |
| Propyl Paraben | 0.02 %w/v |
| Citric Acid | 0.1 %w/v |
| Sodium Citrate | 0.15 %w/v |
| Xanthan Gum | 0.15 %w/v |
| Raspberry Flavour | 0.2 %v/v |
| Purified Water | q.s. to 100 mL |
Purified Water System Record
- System:
- Purified Water (PW) System
- Reference:
- PW-2026-06-03
- Conductivity:
- 0.8 μS/cm (limit: ≤1.3 μS/cm) ✅
- TOC:
- 142 ppb (limit: ≤500 ppb) ✅
- Microbial:
- 12 CFU/mL (limit: ≤100 CFU/mL) ✅
Manufacturing Timeline
| Stage | Start (IST) | End | Duration | Shift |
|---|---|---|---|---|
| Compounding | 03 Jun 2026 22:30:00 IST | 02:30:00 IST | 4 h | Night Shift |
| Filtration | 04 Jun 2026 05:30:00 IST | 07:30:00 IST | 2 h | Night Shift |
| Filling | 04 Jun 2026 17:30:00 IST | 22:30:00 IST | 5 h | Evening Shift |
| Sealing | 05 Jun 2026 01:30:00 IST | 03:30:00 IST | 2 h | Night Shift |
| Packing | 05 Jun 2026 17:30:00 IST | 18:30:00 IST | 1 h | Evening Shift |
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 3 · Compounding & Mixing
- Equipment:
- MX-01 (Pharmatec PTM-500L) — 500 L Compounding Vessel
Serial: MX-PTM-2023-0018 · Liquid Manufacturing Suite
Pre-Compounding Setup
☑ MX-01 vessel cleaned per SOP-LQ-001
☑ Purified Water conductivity verified
☑ All API and excipients weighed per BMR
☑ Temperature control system verified
☑ Line clearance completed (ref: Section 9)
pH Monitoring
| Check # | Time (IST) | Spec | Actual | Status |
|---|---|---|---|---|
| #1 | 03 Jun 2026 22:30:00 IST | 4.5–6.5 pH | 5.3 | ✓ PASS |
| #2 | 03 Jun 2026 23:30:00 IST | 4.5–6.5 pH | 5.6 | ✓ PASS |
| #3 | 04 Jun 2026 00:30:00 IST | 4.5–6.5 pH | 5.6 | ✓ PASS |
Checks: 3 | Mean pH: 5.50 | Min: 5.30 | Max: 5.60 — All within specification ✅
Physical Checks
| Check # | Time (IST) | Parameter | Spec / Observation | Actual | Status |
|---|---|---|---|---|---|
| #4 | 04 Jun 2026 01:30:00 IST | Viscosity | 250–320 cP | 279 cP | ✓ PASS |
| #5 | 04 Jun 2026 02:30:00 IST | Clarity | Clear, free from visible particles | OK | ✓ PASS |
- Operator:
- Priya Sharma (Manufacturing Operator)
- Verified by:
- Rajesh Kumar (QA Manager)
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 4 · Filtration
- Equipment:
- FT-01 — Filtration Unit (Millipore Pellicon 3)
Serial: FT-MIL-2023-0009 - Filter:
- 0.2μm hydrophilic membrane
Filter Integrity Test
- Method:
- Bubble Point
- Specification:
- ASTM F316
- Filter Type:
- 0.2μm Hydrophilic Membrane
- Result:
- PASSED ✅
- Time (IST):
- 04 Jun 2026 05:30:00 IST
- Notes:
- Bubble point integrity test passed. Filter: 0.2μm membrane
Post-Filtration Checks
| Check # | Time (IST) | Parameter | Spec | Actual | Status |
|---|---|---|---|---|---|
| #7 | 04 Jun 2026 06:30:00 IST | Turbidity | ≤2 NTU | 0.8 NTU | ✓ PASS |
| #8 | 04 Jun 2026 07:30:00 IST | pH (post-filter) | 4.5–6.5 pH | 5.7 pH | ✓ PASS |
- Inspector:
- Rohan Mehta
- Reviewed by:
- Rajesh Kumar (QA Manager)
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 5 · Liquid Filling
- Equipment:
- FL-01 (Romaco Macofar MT 12)
Serial: FL-ROM-2022-0044 · Capacity 120 bottles/min - Container:
- HDPE Bottle 100mL
- Fill Target:
- 100 mL (±1 mL)
Fill Volume
| Check # | Time (IST) | Spec | Actual | Δ | Status |
|---|---|---|---|---|---|
| #9 | 04 Jun 2026 17:30:00 IST | 99–101 mL | 100.1 mL | +0.1 mL | ✓ PASS |
| #10 | 04 Jun 2026 19:30:00 IST | 99–101 mL | 99.9 mL | -0.1 mL | ✓ PASS |
| #11 | 04 Jun 2026 21:30:00 IST | 99–101 mL | 99.9 mL | -0.1 mL | ✓ PASS |
Checks: 3 | Mean: 99.97 mL | Min: 99.90 mL | Max: 100.10 mL — All within specification ✅
Appearance
Visual inspection: Clear liquid, correct fill level ✅ PASS
- Operator:
- Sanjay Khanna
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 6 · Container Closure & Sealing
- Equipment:
- SC-01 (Neri Capper TL 50)
Serial: SC-NER-2022-0031
Torque Test
| Check # | Time (IST) | Spec | Actual (N·cm) | Status |
|---|---|---|---|---|
| #13 | 05 Jun 2026 01:30:00 IST | 15–25 N·cm | 19 | ✓ PASS |
Container Closure Integrity (CCI)
- Method:
- Induction Seal Verification
- Sample:
- 100% inspection
- Result:
- PASSED ✅
- Notes:
- Induction seal intact. No leakage.
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 7 · Yield Reconciliation
- Theoretical:
- 5,000 bottles
- Actual:
- 4,825 bottles
- Yield %:
- 96.5%
- Rejected/Loss:
- 175 bottles
- Loss Rate:
- 3.50%
- Assessment:
- ✅ ACCEPTABLE
† Yield loss attributed to filling line startup waste, filter hold-up volume, and QC sampling. Within permitted process variance per SOP-YLD-003.
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 8 · Purified Water System Monitoring
- Water System:
- Purified Water (PW)
- Reference:
- PW-2026-06-03
- Period:
- 03 Jun 2026 — 05 Jun 2026
| Parameter | Limit | Recorded | Status |
|---|---|---|---|
| Conductivity | ≤1.3 μS/cm | 0.8 μS/cm | ✅ |
| TOC | ≤500 ppb | 142 ppb | ✅ |
| Microbial Count | ≤100 CFU/mL | 12 CFU/mL | ✅ |
| pH | 5.0–7.0 | 6.4 | ✅ |
| Endotoxin | ≤0.25 EU/mL | <0.03 EU/mL | ✅ |
Purified Water meets Ph.Eur. 0008, USP <1231>, and Schedule M requirements. All parameters within specification throughout manufacturing.
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 9 · Line Clearance
LC-1 — Before Compounding (MX-01)
☑ MX-01 cleaned and inspected per SOP-LQ-001
☑ Purified Water flushed, conductivity verified
☑ Previous batch labels removed
☑ Ingredient weights verified against BMR
- Performed by:
- priya.sharma / Priya Sharma
- Timestamp:
- 03 Jun 2026 22:00:00 IST(2026-06-03 16:30:00 UTC)
- Verified by:
- Rajesh Kumar
- Status:
- ✅ CLEARED
LC-2 — Before Filtration (FT-01)
☑ Filter cartridge installed and integrity tested
☑ FT-01 sanitised with WFI
☑ Previous filtrate cleared
- Performed by:
- rohan.mehta / Rohan Mehta
- Timestamp:
- 04 Jun 2026 05:00:00 IST(2026-06-03 23:30:00 UTC)
- Verified by:
- Rajesh Kumar
- Status:
- ✅ CLEARED
LC-3 — Before Filling (FL-01)
☑ FL-01 purged with Purified Water
☑ Correct bottle size tooling installed
☑ Fill volume calibration verified
- Performed by:
- sanjay.khanna / Sanjay Khanna
- Timestamp:
- 04 Jun 2026 17:00:00 IST(2026-06-04 11:30:00 UTC)
- Verified by:
- Rajesh Kumar
- Status:
- ✅ CLEARED
LC-4 — Before Sealing (SC-01)
☑ SC-01 cleaned and calibrated
☑ Correct cap/closure size installed
☑ Torque calibration verified
- Performed by:
- sanjay.khanna / Sanjay Khanna
- Timestamp:
- 05 Jun 2026 01:00:00 IST(2026-06-04 19:30:00 UTC)
- Verified by:
- Rajesh Kumar
- Status:
- ✅ CLEARED
LC-5 — Before Packing
☑ Packing area cleared of previous batch
☑ Correct carton and label stock confirmed
☑ Printer settings verified for batch details
- Performed by:
- sanjay.khanna / Sanjay Khanna
- Timestamp:
- 05 Jun 2026 17:00:00 IST(2026-06-05 11:30:00 UTC)
- Verified by:
- Rajesh Kumar
- Status:
- ✅ CLEARED
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 10 · Shift Handover Log
Handover 1 — End of Day Shift
- Time:
- 04 Jun 2026 05:30:00 IST Night Shift(2026-06-04 00:00:00 UTC)
- From:
- Priya Sharma (Manufacturing Operator)
- To:
- Rohan Mehta
- Status:
- Compounding complete. pH within specification throughout. MX-01 shut down and sealed. No deviations raised.
- Signed:
- Priya Sharma + Rohan Mehta ✓
Handover 2 — End of Evening Shift
- Time:
- 04 Jun 2026 13:30:00 IST Day Shift(2026-06-04 08:00:00 UTC)
- From:
- Rohan Mehta
- To:
- Sanjay Khanna (Filling Operator)
- Status:
- Filtration complete. Turbidity: 0.8 NTU — PASS. Filter integrity verified. Bulk product cleared for filling. FT-01 cleaned and locked out.
- Signed:
- Rohan Mehta + Sanjay Khanna ✓
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 11 · Deviation & CAPA Summary
✅ No deviations raised during manufacture of batch PAR-L-0011.
Batch Disposition
✅ APPROVED FOR RELEASE
QsutraIPQA · Electronic Batch Record
PAR-L-0011 — Paracetamol Oral Suspension 250mg/5mL
eBR-PAR-L-0011-2026
Section 12 · Electronic Signature Manifest
🔐 RECORD INTEGRITY
⏳ Computing SHA-256…
All 16 in-process checks reviewed and approved by Rajesh Kumar (rajesh.kumar) on 05 Jun 2026.
Signature 1 — Batch Release / QA Approval
- Action:
- Batch PAR-L-0011 approved for release
- Signer:
- Rajesh Kumar
- Role:
- QA Manager
- Method:
- Username + Password (§11.200 compliant)
- Meaning:
- "I certify this liquid batch meets all release criteria per 21 CFR §211.188 and Schedule M. pH, fill volume, filtration, sealing, and water system requirements are within specification. This is my formal QA decision."
- Timestamp (UTC):
- 2026-06-05 16:00:00 UTC
- Facility (IST):
- 05 Jun 2026 21:30:00 IST
- NTP:
- ✅ pool.ntp.org (±0ms)
Signature 2 — Dual Authorisation
- Action:
- Batch PAR-L-0011 dual-sign confirmation
- Signer 1:
- Rajesh Kumar (QA Manager)
- Signer 2:
- Amit Patel (Production Supervisor)
- Method:
- Both components per §11.200
- Timestamp (UTC):
- 2026-06-05 16:00:00 UTC
- Facility (IST):
- 05 Jun 2026 21:30:00 IST
- NTP:
- ✅ pool.ntp.org (±0ms)
This record was generated by QsutraIPQA v1.0. All timestamps in UTC per 21 CFR §11.10(e) and ALCOA+ principles. NTP-synchronised. Batch records are tamper-evident and version-controlled.