Line Clearance Audit Checklist – Manufacturing

1. General Area Readiness

• Production area cleaned and housekeeping records updated.

• Previous batch records, materials, and documents removed.

• No extraneous materials, labels, or components lying around.

• Garbage bins emptied and cleaned.

• Environmental conditions (temperature, humidity, differential pressure) within limits.

2. Equipment Readiness

• Equipment cleaned as per SOP and status label updated (“Cleaned / Ready to Use”).

• Cleaning verification/visual check performed (no residues, damage, or leaks).

• Preventive maintenance / calibration status checked.

• Equipment logbooks updated with last cleaning and usage details.

• Utilities connected properly (compressed air, steam, water, nitrogen).

3. Materials & Components

• Raw materials, packaging materials, and intermediates from previous batches removed.

• Only approved and released materials available for current batch.

• Material status labels (Approved/Quarantine/Rejected) verified.

• Materials issued match the batch manufacturing record (BMR).

• Dispensed materials weighed and labeled properly.

4. Documentation

• Previous batch BMR and logbooks closed and archived.

• New batch BMR available and approved.

• Any deviations, incidents, or OOS issues closed before starting new batch.

• Line clearance checklist signed by responsible production and QA personnel.

5. Packaging Components (if applicable)

• Previous batch labels, cartons, leaflets, shippers removed and destroyed.

• Reconciliation of packaging materials completed for last batch.

• Only approved labels and artworks for the new batch available.

• Overprinting machine set-up verified with correct batch number, expiry, and Mfg. date.

6. Safety & Compliance

• Gowning and personnel hygiene as per SOP.

• Safety measures in place (spill kits, eyewash, fire extinguishers).

• Compliance with cGMP and cross-contamination prevention measures.

• Access control to the area maintained.

Key Elements of Line Clearance

• Double Verification: By Production and QA.

• Documentation: Line clearance checklist signed and dated.

• Objective: Prevent mix-ups, cross-contamination, and ensure batch integrity.

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