Stratogene Pharma
batches/cap met c 0044/ebr
Today
Active
4
Ready
3
Open Dev.
1
Yield 30d
95.3%
OOS 30d
0.09%
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
STRATOGENE PHARMA
Pvt. Ltd.
ELECTRONIC BATCH RECORD
Metformin HCl 500mg Capsules
Batch No: MET-C-0044
Format: CAPSULE | Capsule Size: Size 0 | Shell: HPMC (Vegetarian)
- Facility:
- Stratogene Pharma Pvt. Ltd.
Plot 14, Pharmaceutical SEZ, Bengaluru 560099, Karnataka - Manufacturing Line:
- Line 1
- Batch Size:
- 100,000 capsules
- Blend Reference:
- BLD-MET-2026-060044
- 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-MET-C-0044-2026
✅ RELEASED
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 2 · Manufacturing Overview
Product Profile
- Product Name:
- Metformin HCl 500mg Capsules
- Product Code:
- MET-500-C
- Capsule Size:
- Size 0
- Shell Type:
- HPMC (Vegetarian)
- Fill Weight:
- 620 mg (Tolerance: ±3%)
Spec: 601.4–638.6 mg - Lock Length:
- 22.2 mm
Spec: 21.7–22.7 mm - Capsules / Blister:
- 10
- Blisters / Box:
- 10
Manufacturing Timeline
| Stage | Start (IST) | End | Duration | Shift |
|---|---|---|---|---|
| Filling | 03 Jun 2026 20:30:00 IST | 01:00:00 IST | 4.5 h | Evening Shift |
| Inspection | 04 Jun 2026 21:30:00 IST | 22:30:00 IST | 1 h | Evening Shift |
| Packing | 05 Jun 2026 15:30:00 IST | 17:30:00 IST | 2 h | Evening Shift |
- Total Elapsed:
- 48 h
- Blend Reference:
- BLD-MET-2026-060044
Upstream granulation and blending completed per BMR BLD-MET-2026-060044. Blend uniformity verified before capsule filling commenced.
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 3 · Capsule Filling — In-Process Checks
- Equipment:
- CF-01 (ACG Pam GKF 1200) — Capsule Filling Machine
Serial: CF-GKF-2023-0044 - Operator:
- Priya Sharma (Solid Dosage Operator)
- Verified by:
- Rajesh Kumar (QA Manager)
Pre-Filling Setup
☑ Capsule filling machine cleaned per SOP-CL-012
☑ Tooling size verified: Size 0 tooling installed
☑ Empty capsule shells inspected for defects
☑ Line clearance completed (ref: Section 8)
☑ CF-01 calibration current (Next due: —)
☑ Tooling size verified: Size 0 tooling installed
☑ Empty capsule shells inspected for defects
☑ Line clearance completed (ref: Section 8)
☑ CF-01 calibration current (Next due: —)
Fill Weight & Lock Length Checks
| # | Time (IST) | Parameter | Spec | Actual | Δ | Status |
|---|---|---|---|---|---|---|
| #1 | 20:30:00 IST | Fill Weight | 601.4–638.6 mg | 615.1 mg | -4.9 | ✅ PASS |
| #2 | 21:00:00 IST | Lock Length | 21.7–22.7 mm | 22.2 mm | +0.0 | ✅ PASS |
| #3 | 22:00:00 IST | Fill Weight | 601.4–638.6 mg | 620.1 mg | +0.1 | ✅ PASS |
| #4 | 23:00:00 IST | Fill Weight | 601.4–638.6 mg | 615 mg | -5.0 | ✅ PASS |
Fill Weight Summary:
Checks performed: 3 · Mean: 616.7 mg · Min: 615 mg · Max: 620.1 mg · Range: 5.1 mg
Status: All within specification ✅
Checks performed: 3 · Mean: 616.7 mg · Min: 615 mg · Max: 620.1 mg · Range: 5.1 mg
Status: All within specification ✅
Appearance
| # | Time (IST) | Observation | Status |
|---|---|---|---|
| #6 | 01:00:00 IST | Uniform colour, no defects | ✅ PASS |
Leakage Test
| # | Time (IST) | Sample Size | Observation | Status |
|---|---|---|---|---|
| #5 | 00:00:00 IST | 20 capsules | No leakage observed | ✅ PASS |
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 4 · Capsule Inspection & Polishing
- Equipment:
- CP-01 — Capsule Polishing Machine (Pharma Technology POL-400)
CI-01 — Capsule Inspection Machine (Sensum Inspector 3300) - Inspector:
- Rohan Mehta (QA Inspector)
- Reviewed by:
- Rajesh Kumar (QA Manager)
Polishing Record
- Machine:
- CP-01
- Time:
- 21:30:00 IST IST
- Duration:
- Standard polishing cycle completed
Capsules polished — powder residue removed from shell surface. Approved for AQL inspection.
AQL Inspection
| # | Time (IST) | Parameter | Result | Status |
|---|---|---|---|---|
| #7 | 21:30:00 IST | AQL Inspection Level II | Accepted | ✅ PASS |
AQL INSPECTION — Level II (MIL-STD-1916)
Sample Size: 200 capsules
Critical Defects: 0 (AQL limit: 0) ✅
Major Defects: 0 (AQL limit: 2) ✅
Minor Defects: 0 (AQL limit: 8) ✅
Decision: ACCEPTED
Sample Size: 200 capsules
Critical Defects: 0 (AQL limit: 0) ✅
Major Defects: 0 (AQL limit: 2) ✅
Minor Defects: 0 (AQL limit: 8) ✅
Decision: ACCEPTED
Defect Rate: 1.6% (spec: ≤2.5%) ✅ PASS
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 5 · Primary Packaging — Blister
- Equipment:
- IL-04 (Uhlmann UPS 4 Blister Line) — Packing Hall · Line 4
- Format:
- Blister Pack
- Capsules / Blister:
- 10
- Blisters / Box:
- 10
- Foil type:
- Alu-Alu blister
- Batch No. on pack:
- MET-C-0044
- Operator:
- Sanjay Khanna (Packing Operator)
In-Process Checks
| # | Time (IST) | Parameter | Value / Observation | Status |
|---|---|---|---|---|
| #9 | 15:30:00 IST | Seal Integrity | Blister seal intact | ✅ PASS |
| #10 | 16:30:00 IST | Print Verification | Batch No., Mfg. Date, Exp. Date correct | ✅ PASS |
| #11 | 17:30:00 IST | Count per Blister | 10 caps | ✅ PASS |
All packaging checks passed. Batch cleared for final yield reconciliation.
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 6 · Yield Reconciliation
- Theoretical Yield:
- 100,000 capsules
- Actual Yield:
- 97,200 capsules
- Yield %:
- 97.2%
- Rejected:
- 2,800 capsules
- Rejection Rate:
- 2.80%
- Assessment:
- ✅ ACCEPTABLE — within limits
† Yield variance attributed to capsule polishing waste and AQL inspection samples (destructive testing). Within permitted process variance per SOP-YLD-002. No investigation required (threshold: <5%).
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 7 · Environmental & Utility Monitoring
- Location:
- Capsule Filling Suite — Class 100,000 / ISO 8
- Monitoring Period:
- 03 Jun 2026 — 05 Jun 2026
| Parameter | Limit | Recorded | Status |
|---|---|---|---|
| Temperature | 20–25°C | 22.4°C | ✅ IN RANGE |
| Relative Humidity | 40–60% RH | 52.3% RH | ✅ IN RANGE |
| Differential Pressure | +10–15 Pa | 12.0 Pa | ✅ IN RANGE |
| Particle Count (0.5μm) | ≤3,520/m³ | 2,840/m³ | ✅ IN RANGE |
Humidity Note: HPMC shell humidity monitoring critical. RH maintained within 40–60% throughout filling. No brittleness or softening observed.
Empty Capsule Shell Lot
- Supplier:
- Capsugel / ACG
- Lot No.:
- CAPS-MET-C-0044-SHELL-01
- CoA Reference:
- COA-SHELL-2026-MET-C-0044
- Inspection:
- ✅ Passed incoming QC
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 8 · Line Clearance
LC-1 — Before Capsule Filling (CF-01)
☑ Previous product/batch materials removed
☑ CF-01 cleaning verified per SOP-CL-012
☑ Capsule size tooling installed and verified (Size 0)
☑ Fill weight calibration check performed
☑ No foreign materials in filling area
- Performed by:
- Priya Sharma
- Timestamp:
- 03 Jun 2026 20:00:00 IST(2026-06-03 14:30:00 UTC)
- Verified by:
- Rajesh Kumar (QA Manager)
- E-Signature:
- 03 Jun 2026 20:00:00 IST ✅
LC-2 — Before Inspection (CI-01)
☑ Polishing machine CP-01 cleaned
☑ Inspection machine CI-01 calibrated
☑ Previous batch samples cleared
☑ AQL sampling plan documented
- Performed by:
- Rohan Mehta
- Timestamp:
- 04 Jun 2026 21:00:00 IST(2026-06-04 15:30:00 UTC)
- Verified by:
- Rajesh Kumar (QA Manager)
- E-Signature:
- 04 Jun 2026 21:00:00 IST ✅
LC-3 — Before Packing (IL-04)
☑ Previous product remnants cleared from IL-04
☑ Correct blister tooling installed
☑ Foil stock verified (correct batch details)
☑ Printer settings verified for batch number/dates
- Performed by:
- Sanjay Khanna
- Timestamp:
- 05 Jun 2026 15:00:00 IST(2026-06-05 09:30:00 UTC)
- Verified by:
- Rajesh Kumar (QA Manager)
- E-Signature:
- 05 Jun 2026 15:00:00 IST ✅
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 9 · Shift Handover Log
Handover 1 — End of Day Shift
- Time:
- 04 Jun 2026 03:30:00 IST(2026-06-03 22:00:00 UTC)
- From:
- Priya Sharma (Solid Dosage Operator)
- To:
- Rohan Mehta (Inspection / Next Shift)
- Status:
- Capsule filling Stage 1 complete. 3 fill weight checks completed. CF-01 shut down per SOP. No open deviations.
- Signed:
- Priya Sharma + Rohan Mehta ✓
Handover 2 — End of Evening Shift
- Time:
- 04 Jun 2026 11:30:00 IST(2026-06-04 06:00:00 UTC)
- From:
- Rohan Mehta
- To:
- Sanjay Khanna (Packing Operator)
- Status:
- Inspection complete. AQL ACCEPTED. 97,200 capsules cleared for packing. CP-01 and CI-01 cleaned and locked out.
- Signed:
- Rohan Mehta + Sanjay Khanna ✓
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 10 · Deviation & CAPA Summary
Deviations
✅ No deviations raised during manufacture of batch MET-C-0044.
Associated CAPAs
No CAPAs associated with this batch.
Batch Disposition
✅ APPROVED FOR RELEASE
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 11 · Final Yield Summary & Reconciliation
| Stage | Input (caps) | Output (caps) | Loss | Loss % |
|---|---|---|---|---|
| Filling | 100,000 | 99,067 | 933 | 0.93% |
| Polishing | 99,067 | 98,600 | 467 | 0.47% |
| Inspection* | 98,600 | 97,200 | 1,400 | 1.40% |
| Packing | 97,200 | 97,200 | 0 | 0.00% |
| TOTAL | 100,000 | 97,200 | 2,800 | 2.80% |
* AQL samples (200 capsules destructive) + polishing waste.
QA Sign-off
- Reviewed by:
- Rajesh Kumar
- Timestamp:
- 05 Jun 2026 19:30:00 IST(2026-06-05 14:00:00 UTC)
QsutraIPQA · Electronic Batch Record
MET-C-0044 — Metformin HCl 500mg Capsules
eBR-MET-C-0044-2026
Section 12 · Electronic Signature Manifest
🔐 RECORD INTEGRITY
⏳ Computing SHA-256…
All 11 in-process checks reviewed and approved by Rajesh Kumar (rajesh.kumar) on 05 Jun 2026.
Signature 1 — Batch Release / QA Approval
- Action:
- Batch MET-C-0044 approved for release
- Signer:
- Rajesh Kumar
- Role:
- QA Manager
- Method:
- Username + Password (§11.200 compliant)
- Meaning:
- "I certify this batch meets all release criteria per 21 CFR §211.188 and Schedule M. This release is my formal QA decision."
- Timestamp (UTC):
- 2026-06-05 14:00:00 UTC
- Facility (IST):
- 05 Jun 2026 19:30:00 IST
- NTP:
- ✅ pool.ntp.org (±0ms)
Signature 2 — Dual Authorisation
- Action:
- Batch MET-C-0044 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 14:00:00 UTC
- Facility (IST):
- 05 Jun 2026 19:30:00 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.