PAR-L-0011

Closed🧪 Liquid

Paracetamol Oral Suspension 250mg/5mL · Line 5 · 5,000 bottles

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Container: HDPE Bottle 100mL

Batch Size: 5,000 bottles

Line: Line 5 · Liquid Manufacturing Suite

pH Target: 5.5 (spec: 4.5–6.5)

Fill Volume: 100mL (±1mL)

Viscosity: 280cP (spec: 250–320)

Batch Formula Ref: BF-PAR-2026-0011

Water System Ref: PW-2026-06-03

🧪 Compounding→🔬 Filtration→💧 Filling→🔒 Sealing→📦 Packing

Theoretical yield

Actual

Yield %

96.5%

🔐 SHA-256:computing…

Sealed 05 Jun 2026, 21:30 IST · ✅ Verified

In-process checks

#	Stage	Mode	Parameter	Value	Spec	Status	Operator	Timestamp	Reviewed By
1	Compounding	Steady State	pH	5.3 pH	4.5–6.5 pH	Pass	Priya Sharma	6/3/2026, 5:00:00 PM	✅ Rajesh Kumar
2	Compounding	Steady State	pH	5.6 pH	4.5–6.5 pH	Pass	Priya Sharma	6/3/2026, 6:00:00 PM	✅ Rajesh Kumar
3	Compounding	Steady State	pH	5.6 pH	4.5–6.5 pH	Pass	Priya Sharma	6/3/2026, 7:00:00 PM	✅ Rajesh Kumar
4	Compounding	Steady State	Viscosity	279 cP	250–320 cP	Pass	Priya Sharma	6/3/2026, 8:00:00 PM	✅ Rajesh Kumar
5	Compounding	Steady State	Clarity	1 visual	1–1 visual	Pass	Priya Sharma	6/3/2026, 9:00:00 PM	✅ Rajesh Kumar
6	Filtration	Steady State	Filter Integrity Test	1 visual	1–1 visual	Pass	Rohan Mehta	6/4/2026, 12:00:00 AM	✅ Rajesh Kumar
7	Filtration	Steady State	Turbidity	0.8 NTU	0–2 NTU	Pass	Rohan Mehta	6/4/2026, 1:00:00 AM	✅ Rajesh Kumar
8	Filtration	Steady State	pH (post-filter)	5.7 pH	4.5–6.5 pH	Pass	Rohan Mehta	6/4/2026, 2:00:00 AM	✅ Rajesh Kumar
9	Filling	Initial Mode	Fill Volume	100.1 mL	99–101 mL	Pass	Sanjay Khanna	6/4/2026, 12:00:00 PM	✅ Rajesh Kumar
10	Filling	Initial Mode	Fill Volume	99.9 mL	99–101 mL	Pass	Sanjay Khanna	6/4/2026, 2:00:00 PM	✅ Rajesh Kumar
11	Filling	Run Mode	Fill Volume	99.9 mL	99–101 mL	Pass	Sanjay Khanna	6/4/2026, 4:00:00 PM	✅ Rajesh Kumar
12	Filling	Run Mode	Appearance	1 visual	1–1 visual	Pass	Sanjay Khanna	6/4/2026, 5:00:00 PM	✅ Rajesh Kumar
13	Sealing	Steady State	Torque Test	19 N·cm	15–25 N·cm	Pass	Sanjay Khanna	6/4/2026, 8:00:00 PM	✅ Rajesh Kumar
14	Sealing	Steady State	Container Closure Integrity	1 visual	1–1 visual	Pass	Sanjay Khanna	6/4/2026, 10:00:00 PM	✅ Rajesh Kumar
15	Packing	Steady State	Print Verification	1 visual	1–1 visual	Pass	Sanjay Khanna	6/5/2026, 12:00:00 PM	✅ Rajesh Kumar
16	Packing	Steady State	Bottle Count per Shipper	12 bottles	12–12 bottles	Pass	Sanjay Khanna	6/5/2026, 1:00:00 PM	✅ Rajesh Kumar

Audit trail (this batch)

Batch started6/3/2026, 4:00:00 PM
Check #1 recorded — pH 5.3pH (PASS)Priya Sharma · 6/3/2026, 5:00:00 PM
Check #2 recorded — pH 5.6pH (PASS)Priya Sharma · 6/3/2026, 6:00:00 PM
Check #3 recorded — pH 5.6pH (PASS)Priya Sharma · 6/3/2026, 7:00:00 PM
Check #4 recorded — Viscosity 279cP (PASS)Priya Sharma · 6/3/2026, 8:00:00 PM
Check #5 recorded — Clarity 1visual (PASS)Priya Sharma · 6/3/2026, 9:00:00 PM
Check #6 recorded — Filter Integrity Test 1visual (PASS)Rohan Mehta · 6/4/2026, 12:00:00 AM
Check #7 recorded — Turbidity 0.8NTU (PASS)Rohan Mehta · 6/4/2026, 1:00:00 AM
Check #8 recorded — pH (post-filter) 5.7pH (PASS)Rohan Mehta · 6/4/2026, 2:00:00 AM
Check #9 recorded — Fill Volume 100.1mL (PASS)Sanjay Khanna · 6/4/2026, 12:00:00 PM
Check #10 recorded — Fill Volume 99.9mL (PASS)Sanjay Khanna · 6/4/2026, 2:00:00 PM
Check #11 recorded — Fill Volume 99.9mL (PASS)Sanjay Khanna · 6/4/2026, 4:00:00 PM
Check #12 recorded — Appearance 1visual (PASS)Sanjay Khanna · 6/4/2026, 5:00:00 PM
Check #13 recorded — Torque Test 19N·cm (PASS)Sanjay Khanna · 6/4/2026, 8:00:00 PM
Check #14 recorded — Container Closure Integrity 1visual (PASS)Sanjay Khanna · 6/4/2026, 10:00:00 PM
Check #15 recorded — Print Verification 1visual (PASS)Sanjay Khanna · 6/5/2026, 12:00:00 PM
Check #16 recorded — Bottle Count per Shipper 12bottles (PASS)Sanjay Khanna · 6/5/2026, 1:00:00 PM
Batch closed & locked by Rajesh Kumar6/5/2026, 4:00:00 PM

🔍 Audit Readiness: 71/100 (CDSCO)

Last inspection: 15 Mar 2026 | Next: 05 Aug 2026

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