PAR-L-0010

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-2026-0010

Water System Ref: PW-2026-05-14

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

Theoretical yield

Actual

Yield %

98.1%

🔐 SHA-256:computing…

Sealed 17 May 2026, 05:12 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	5/15/2026, 12:42:51 AM	✅ Rajesh Kumar
2	Compounding	Steady State	pH	5.7 pH	4.5–6.5 pH	Pass	Priya Sharma	5/15/2026, 1:42:51 AM	✅ Rajesh Kumar
3	Compounding	Steady State	pH	5.3 pH	4.5–6.5 pH	Pass	Priya Sharma	5/15/2026, 2:42:51 AM	✅ Rajesh Kumar
4	Compounding	Steady State	Viscosity	290 cP	250–320 cP	Pass	Priya Sharma	5/15/2026, 3:42:51 AM	✅ Rajesh Kumar
5	Compounding	Steady State	Clarity	1 visual	1–1 visual	Pass	Priya Sharma	5/15/2026, 4:42:51 AM	✅ Rajesh Kumar
6	Filtration	Steady State	Filter Integrity Test	1 visual	1–1 visual	Pass	Rohan Mehta	5/15/2026, 7:42:51 AM	✅ Rajesh Kumar
7	Filtration	Steady State	Turbidity	0.9 NTU	0–2 NTU	Pass	Rohan Mehta	5/15/2026, 8:42:51 AM	✅ Rajesh Kumar
8	Filtration	Steady State	pH (post-filter)	5.2 pH	4.5–6.5 pH	Pass	Rohan Mehta	5/15/2026, 9:42:51 AM	✅ Rajesh Kumar
9	Filling	Initial Mode	Fill Volume	100.1 mL	99–101 mL	Pass	Sanjay Khanna	5/15/2026, 7:42:51 PM	✅ Rajesh Kumar
10	Filling	Initial Mode	Fill Volume	100.1 mL	99–101 mL	Pass	Sanjay Khanna	5/15/2026, 9:42:51 PM	✅ Rajesh Kumar
11	Filling	Run Mode	Fill Volume	99.9 mL	99–101 mL	Pass	Sanjay Khanna	5/15/2026, 11:42:51 PM	✅ Rajesh Kumar
12	Filling	Run Mode	Appearance	1 visual	1–1 visual	Pass	Sanjay Khanna	5/16/2026, 12:42:51 AM	✅ Rajesh Kumar
13	Sealing	Steady State	Torque Test	21 N·cm	15–25 N·cm	Pass	Sanjay Khanna	5/16/2026, 3:42:51 AM	✅ Rajesh Kumar
14	Sealing	Steady State	Container Closure Integrity	1 visual	1–1 visual	Pass	Sanjay Khanna	5/16/2026, 5:42:51 AM	✅ Rajesh Kumar
15	Packing	Steady State	Print Verification	1 visual	1–1 visual	Pass	Sanjay Khanna	5/16/2026, 7:42:51 PM	✅ Rajesh Kumar
16	Packing	Steady State	Bottle Count per Shipper	12 bottles	12–12 bottles	Pass	Sanjay Khanna	5/16/2026, 8:42:51 PM	✅ Rajesh Kumar

Audit trail (this batch)

Batch started5/14/2026, 11:42:51 PM
Check #1 recorded — pH 5.3pH (PASS)Priya Sharma · 5/15/2026, 12:42:51 AM
Check #2 recorded — pH 5.7pH (PASS)Priya Sharma · 5/15/2026, 1:42:51 AM
Check #3 recorded — pH 5.3pH (PASS)Priya Sharma · 5/15/2026, 2:42:51 AM
Check #4 recorded — Viscosity 290cP (PASS)Priya Sharma · 5/15/2026, 3:42:51 AM
Check #5 recorded — Clarity 1visual (PASS)Priya Sharma · 5/15/2026, 4:42:51 AM
Check #6 recorded — Filter Integrity Test 1visual (PASS)Rohan Mehta · 5/15/2026, 7:42:51 AM
Check #7 recorded — Turbidity 0.9NTU (PASS)Rohan Mehta · 5/15/2026, 8:42:51 AM
Check #8 recorded — pH (post-filter) 5.2pH (PASS)Rohan Mehta · 5/15/2026, 9:42:51 AM
Check #9 recorded — Fill Volume 100.1mL (PASS)Sanjay Khanna · 5/15/2026, 7:42:51 PM
Check #10 recorded — Fill Volume 100.1mL (PASS)Sanjay Khanna · 5/15/2026, 9:42:51 PM
Check #11 recorded — Fill Volume 99.9mL (PASS)Sanjay Khanna · 5/15/2026, 11:42:51 PM
Check #12 recorded — Appearance 1visual (PASS)Sanjay Khanna · 5/16/2026, 12:42:51 AM
Check #13 recorded — Torque Test 21N·cm (PASS)Sanjay Khanna · 5/16/2026, 3:42:51 AM
Check #14 recorded — Container Closure Integrity 1visual (PASS)Sanjay Khanna · 5/16/2026, 5:42:51 AM
Check #15 recorded — Print Verification 1visual (PASS)Sanjay Khanna · 5/16/2026, 7:42:51 PM
Check #16 recorded — Bottle Count per Shipper 12bottles (PASS)Sanjay Khanna · 5/16/2026, 8:42:51 PM
Batch closed & locked by Rajesh Kumar5/16/2026, 11:42:51 PM

🔍 Audit Readiness: 71/100 (CDSCO)

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

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