with GMP and regulatory standards.

2. Scope

This SOP applies to all primary and secondary packaging lines, rooms, and equipment used for the packaging of injectable pharmaceutical products within the Packaging Department.

3. Responsibilities

• Packaging Operator: Conducts physical cleaning and assists in the line clearance process.
• Packaging Supervisor: Ensures the line is properly cleared and documents the clearance.
• Quality Assurance (QA) Officer: Verifies the line clearance and gives authorization to start packaging.

4. Accountability

The Head of Packaging is accountable for implementing and ensuring adherence to this SOP.

5. Procedure

5.1 Pre-Clearance Preparation

1. Ensure completion and closure of all packaging activities for the previous batch.
2. Dispose of all waste materials as per waste handling SOP.
3. Ensure the area is cleaned following the SOP for cleaning of packaging areas.

5.2 Execution of Line Clearance

1. Verify that all packaging components from the previous batch (cartons, leaflets, labels, vials, etc.) are removed.
2. Ensure that no product remnants are left on the packaging equipment or floors.
3. Ensure removal of all batch records, printed material, stickers, and signs related to the previous product.
4. Inspect machines (labeling, blister, cartooning, sealing) for any residual material or documents.
5. Check weighing balance calibration stickers, environmental status display, and room cleaning logs.
6. Fill in the Line Clearance Checklist (Annexure-1) item-wise.

5.3 Verification by QA

1. QA Officer shall physically inspect the entire packaging area and equipment.
2. Cross-verify entries made by the packaging supervisor in the Line Clearance Checklist.
3. Sign the Line Clearance Checklist with date and time to authorize the start of packaging.

5.4 Documentation

1. Maintain the Line Clearance Checklist with the batch packaging records.
2. QA to retain a copy of the signed checklist as per document retention policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Line Clearance Checklist – Annexure-1

8. References

• WHO TRS 961 Annex 6: GMP for Pharmaceutical Products
• ICH Q7: GMP for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Packaging Officer	QA Executive	Head QA
Department	Packaging	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Line Clearance Checklist

Area	Check Item	Status (Cleared/Not Cleared)	Remarks	Checked By	Date
Packaging Room 1	No leftover materials from previous batch	Cleared	OK	Rajesh Kumar	24/06/2025
Packaging Room 1	Machines cleaned and ready	Cleared	OK	Rajesh Kumar	24/06/2025

Revision History

Revision Date	Revision No.	Revision Details	Reason	Approved By
01/05/2022	1.0	Initial release	New SOP	Head QA
24/06/2025	2.0	Updated checklist format and added QA verification section	GMP Compliance Update	Head QA