Pharma Line Clearance Record Template
Line clearance is the documented check that a line is free of the previous product, materials and documents before the next batch starts. This template gives you a clean one-page record you can adapt to your own SOP and print or export.
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Pharma Line Clearance Record Template
Line Clearance Record
Site: Unit 2 Oral Solid Dosage Line / room: PKG-LINE-04 Date: 2026-10-20 Clearance type: Product changeover Previous: Metformin 500 mg tablets, batch MT2410-017 Next: Amlodipine 5 mg tablets, batch AM2410-003
Clearance Checks
| No. | Check | Done (Y/N/NA) | Initials |
|---|---|---|---|
| 1 | Previous batch product, bulk and rejects removed from line and room | ||
| 2 | Previous batch printed materials, labels and cartons removed or reconciled | ||
| 3 | Batch coding equipment cleared of old codes and test prints | ||
| 4 | Line and equipment visibly clean, cleaning status label current | ||
| 5 | Only materials for Amlodipine 5 mg tablets, batch AM2410-003 present at the line | ||
| 6 | Documents of the previous batch removed from the area | ||
| 7 | Balances and checkweigher verified, calibration in date | ||
| 8 | Room temperature and humidity within the stated limits |
Remarks
None. Residual printed foil from previous batch found in reject bin, removed and destroyed before start.
Sign-off
A starting point for your own SOP. Match the check list to your line, product risk and approved procedure. QA verification of the first line clearance is common practice but follow your quality system.
Line clearance inside your batch record
Want clearance checks captured digitally and tied to the batch in your ERP? Ask for an expert review of your setup.
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How to use the template
Fill in the site, line and the previous and next product. Choose the clearance type, then print the check table and have the operator tick each item as the line is physically walked. Fill the remarks field with anything found, such as stray labels or residual product. The supervisor signs after the operator, and QA verifies according to your procedure. Export to Word if you need to add line specific checks before releasing it as a controlled form.
- One record per line and per start or changeover event
- Initial each check, never tick on behalf of someone else
- Record anything found as a remark even if it was fixed on the spot
What regulators look for
EU GMP Chapter 5 (Production) expects checks before operations that the area and equipment are clean and free from any starting materials, products or documents not required for the planned operation. 21 CFR 211.130 requires inspection of packaging and labelling facilities before use to ensure that drugs have been removed from previous operations. Auditors typically sample line clearance records against the batch record and look for signs of pre-filling or copied initials.
Common mistakes
The most frequent finding is a generic check list that does not reflect the actual line, so operators tick items without looking. Others are clearance done by one person and signed by another, missing time of the check, and no evidence that printed materials were reconciled. Fix these by keeping the list short, specific to the line and giving the time of the check in your final controlled version.
- Do not pre-sign before the physical walk of the line
- Include coding equipment and rework bins, not only the conveyor
- Link the record to the batch number so it can be found in review
Frequently Asked Questions
Is a line clearance record the same as a cleaning record?
No. Cleaning records show that equipment was cleaned to a validated or approved method. Line clearance confirms the line is free of the previous batch's materials and documents at the point of starting the next one. They are both needed but answer different questions.
Who must sign a line clearance?
The operator and supervisor normally sign, and many sites require QA to verify at least the start of each batch or a changeover. The exact rule belongs in your SOP, which should be approved by your quality unit.
How long do I keep the record?
Keep it as part of the batch documentation. EU GMP generally expects batch records for at least one year after expiry of the batch or five years after certification, whichever is longer. Check your local regulation and your retention SOP.
Can I use this form as is?
Use it as a draft. Add your document number, version and effective date, tailor the checks to the line, and have it approved under your document control system before use on the floor.
If you want line clearance steps captured on tablets and linked to the batch record in your ERP or MES, Netray can help design and build that integration.
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