using semi-automatic or automatic labeling machines.

3. Responsibilities

• Labeling Operator: Responsible for machine setup, operation, and in-process checks.
• Packaging Supervisor: Monitors process compliance and reviews documentation.
• Quality Assurance: Performs line clearance and labeling verification checks.

4. Accountability

The Head of Gel Manufacturing is accountable for ensuring the labeling operation is performed as per this SOP.

5. Procedure

5.1 Pre-Operation Checks

1. Verify that the labeling machine is clean and labeled with the correct equipment status tag.
2. Ensure the machine is in proper working condition and all safety guards are intact.
3. Ensure all label rolls are verified and approved by QA prior to loading.

5.2 Line Clearance

1. QA shall perform and document the line clearance (Annexure-1) prior to label application.
2. Ensure that previous product labels, tubes, or jars have been removed from the area.

5.3 Labeling Machine Setup

1. Load the approved label roll on the unwind spool of the labeling machine.
2. Thread the label through the rollers and sensor system as per manufacturer’s manual.
3. Set the label placement parameters (height, angle, orientation) depending on container type.
4. Conduct trial runs with empty containers to verify correct label alignment.

5.4 Labeling Operation

1. Start the machine and initiate labeling of filled gel tubes or jars.
2. Continuously monitor label alignment, adhesion quality, and label integrity.
3. In-process checks to be done every 30 minutes and recorded in the Labeling Log (Annexure-2).
4. Immediately segregate any units with label defects and report to QA.

5.5 Post-Operation

1. Stop the machine and remove the remaining labels, cores, and trims.
2. Clean the labeling unit and rollers using lint-free cloth and approved cleaning agent.
3. Affix “Cleaned” status label on the machine and document cleaning activity.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BPR: Batch Packaging Record
• GMP: Good Manufacturing Practice

7. Documents

1. Batch Packaging Record (BPR)
2. Label Approval Record
3. Labeling Logbook – Annexure-2
4. Line Clearance Form – Annexure-1

8. References

• Labeling Equipment Manufacturer’s Manual
• GMP Guidelines (Schedule M)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Line Clearance Form

Date	Batch No.	Machine ID	Previous Material Removed	Area Cleaned	QA Signature
			Yes / No	Yes / No

Annexure-2: Labeling Logbook

Date	Time	Batch No.	Label Alignment	Defect Observed	Corrective Action	Checked By (QA)
			Yes / No	None / Misalignment / Missing

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/05/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Format and annexures updated	Review and update	QA Head