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Electronic Batch Record · eBR-MET-0889-2026
STRATOGENE PHARMA
Pvt. Ltd.

ELECTRONIC BATCH RECORD

Product:
Metformin HCl 500mg Tablets
Batch Number:
MET-0889
Batch Size:
50 kg (approx. 500,000 tablets)
Manufacturing:
21 May 2026 — 24 May 2026
Packaging Type:
BLISTER (Primary)
Manufactured by:
Stratogene Pharma Pvt. Ltd.
Plot 14, Pharma SEZ, Bengaluru, Karnataka 560099
QA Released by:
Rajesh Kumar, QA Manager
Release Date:
24 May 2026
Document ID:
eBR-MET-0889-2026
System:
QsutraIPQA v1.0
SHA-256 Hash:
f29436d87a1cbe50f29436d87a1cbe50f29436d87a1cbe50f29436d87a1cbe50
✓ RELEASED — Approved for Distribution
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 1 of 12

Batch Summary

1. Product Information

Product Name:
Metformin HCl 500mg Tablets
Product Code:
MET-500-T
Batch Number:
MET-0889
Manufacturing Line:
Line 1
Batch Size:
50 kg theoretical

2. Manufacturing Timeline

Batch Initiated:
21 May 2026  06:00:00 IST Day Shift
(2026-05-21 00:30:00 UTC)
Stage 1: Compression:
21 May 2026  06:30:00 IST Day Shift → 09:00:00 IST
Duration: 2.5 hours
(2026-05-21 01:00:00 UTC → 2026-05-21 03:30:00 UTC)
Stage 2: Coating:
22 May 2026  06:00:00 IST Day Shift → 07:00:00 IST
Duration: 1 hours
(2026-05-22 00:30:00 UTC → 2026-05-22 01:30:00 UTC)
Stage 3: Packing (BLISTER):
23 May 2026  06:00:00 IST Day Shift → 07:00:00 IST
Duration: 1 hours
(2026-05-23 00:30:00 UTC → 2026-05-23 01:30:00 UTC)
Batch Closed (QA Release):
24 May 2026  18:00:00 IST Evening Shift
(2026-05-24 12:30:00 UTC)

3. Yield Summary

Theoretical Yield:
50.00 kg
Actual Yield:
48.25 kg
Yield %:
96.5% ✓ (Target: 95–102%)
Losses:
1.75 kg (3.5%) — 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:
24 May 2026 18:00:00 IST(2026-05-24 12:30:00 UTC)
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 2 of 12

Stage 1: Compression — IPQA Check Results

Equipment:
Compression Machine A (Line 1)
Operator:
Priya Sharma (QA Operator — Compression)
Checks Performed:
8 | Pass: 8 | OOS: 0
Check #TimeFill Wt (mg)Hardness (kP)Friability (%)Thickness (mm)Status
#108:30 IST201.29.40.64.2✓ PASS
#209:15 IST200.89.20.74.1✓ PASS
#310:00 IST201.59.50.64.2✓ PASS
#410:45 IST200.39.30.74.1✓ PASS
#511:30 IST201.19.40.64.2✓ PASS
#613:00 IST200.99.20.64.1✓ PASS
#713:45 IST201.39.50.74.2✓ PASS
#814:00 IST200.79.30.64.1✓ 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
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 3 of 12

Stage 2: Coating — IPQA Check Results

Equipment:
Coating Pan — Line 1
Operator:
Rohan Mehta (QA Operator — Coating)
Checks Performed:
4 | Pass: 4 | OOS: 0
Check #TimeWeight Gain (%)Pan Temp (°C)Pan Speed (RPM)Status
#115:00 IST4.150.225✓ PASS
#217:00 IST4.250.425✓ PASS
#319:00 IST4.150.125✓ PASS
#421:00 IST4.250.325✓ PASS
Specification: Weight Gain 3.5–4.5% | Pan Temp 48–52°C | Pan Speed 20–30 RPM
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 4 of 12

Stage 3: Packing (BLISTER)

Equipment:
Blister Packing Machine — Line 1
Operator:
Sanjay Khanna (QA Operator — Packing)
Checks Performed:
8 | Pass: 8 | OOS: 0
Check #TimeTablet CountSealPrint QualityStatus
#109:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#210:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#311:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#412:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#513:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#614:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#715:00 IST10 ✓Intact ✓Legible ✓✓ PASS
#816:00 IST10 ✓Intact ✓Legible ✓✓ PASS
Stage Summary: ✓ ALL CHECKS WITHIN SPECIFICATION
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 5 of 12

Critical Control Point: Metal Detector Validation

Equipment:
Metal Detector — Line 1
Validation Date:
24 May 2026
Validated by:
Sanjay Khanna

Challenge Test Results

TestTest PieceResultStatus
1Ferrous (1.5 mm)DETECT✓ PASS
2Non-Ferrous (2.0 mm)DETECT✓ PASS
3Stainless (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
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 6 of 12

Environmental Monitoring Log

Monitoring Period:
21 May 2026 — 24 May 2026
Total Readings:
12
Date/TimeLocationTemp (°C)Humidity (%)Pressure (Pa)Status
02 Jun 08:00Compression22.146+12✓
02 Jun 14:00Compression22.348+11✓
02 Jun 20:00Compression2247+12✓
03 Jun 08:00Coating22.449+11✓
03 Jun 14:00Coating22.248+12✓
03 Jun 20:00Coating22.147+11✓
04 Jun 08:00Packing22.346+12✓
04 Jun 11:00Packing22.548+11✓
04 Jun 14:00Packing22.449+12✓
04 Jun 17:00Packing22.247+11✓
04 Jun 20:00Packing22.146+12✓
05 Jun 08:00QC Lab2245+11✓
Acceptable Ranges: Temp 19–25°C | Humidity 35–55% | Pressure > +10 Pa
✓ All readings within acceptable limits
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 7 of 12

Line Clearance Log

Total Line Clearances: 0

CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 8 of 12

Shift Handover Log

Total Handovers: 0

CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 9 of 12

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.

CAPA Summary

Total CAPAs:
0
Status: ✓ NO CAPAs REQUIRED
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 10 of 12

Yield Reconciliation

Input Material

Raw Material Input:
50.00 kg
Granulation Weight:
49.50 kg

Output Breakdown

ComponentWeight (kg)%
Finished Product48.2596.5%
Rejected Tablets0.000.0%
In-Process Samples0.501.0%
Line Waste0.751.5%
Retained Samples0.250.5%
Unaccounted0.251.0%
Total Output50.00100.0%
Yield: 96.5% ✓ Within acceptable limits (95–102%)
Reconciliation certified by: Amit Patel (Production Supervisor)
Certification Date: 24 May 2026
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 11 of 12

Electronic Signature Manifest

(21 CFR Part 11 Compliant)

Signature 1 — Batch Closure Authorization

Signed by:
Rajesh Kumar
Role:
QA Manager
Department:
Quality Assurance
Action:
Batch MET-0889 approved for release
Method:
USERNAME + PASSWORD (Two-component, 21 CFR §11.200)
Session:
First signing (full components)
Signed (UTC):
2026-05-24 12:30:00 UTC
Facility (IST):
24 May 2026 18:00:00 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."
Hash:
f29436d87a1cbe50f29436d87a1cbe50…

Signature 2 — Independent Release Verification

Signed by:
Rajesh Kumar
Role:
QA Manager
Department:
Quality Assurance
Action:
Independent verification — Batch MET-0889
Method:
USERNAME + PASSWORD (Two-component, 21 CFR §11.200)
Session:
First signing (full components)
Signed (UTC):
2026-05-24 12:30:00 UTC
Facility (IST):
24 May 2026 18:00:00 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)

TimestampUserAction
24 May 2026 14:32:47 UTCRajesh KumarBatch MET-0889 closed and released
24 May 2026 14:32:00 UTCRajesh KumarE-signature applied to closure
24 May 2026 14:30:00 UTCRajesh KumarClosure checklist completed
24 May 2026 10:00:00 UTCAmit PatelYield reconciliation submitted
24 May 2026 16:00:00 UTCSanjay KhannaPacking check #8 entered (PASS)
24 May 2026 08:30:00 UTCSanjay KhannaLine clearance (Packing) signed
21 May 2026 15:00:00 UTCRohan MehtaCoating stage started
21 May 2026 08:00:00 UTCAmit PatelBatch MET-0889 initiated

Document Integrity

SHA-256 Hash:
f29436d87a1cbe50f29436d87a1cbe50f29436d87a1cbe50f29436d87a1cbe50
Generated:
2026-05-24 12:30:00 UTC
System:
QsutraIPQA v1.0
Version:
Immutable — locked on batch closure
CONFIDENTIAL | eBR-MET-0889-2026 | QsutraIPQA v1.0 | Page 12 of 12