Responsibilities

• Packaging Operator: Apply labels correctly and verify each label’s clarity and correctness.
• Supervisor: Confirm labeling setup, monitor label reconciliation, and escalate issues.
• Quality Assurance: Conduct in-process checks and approve labeling line before use.

4. Accountability

The Head – Manufacturing is accountable for the integrity and traceability of all labeled gel products.

5. Procedure

5.1 Pre-Labeling Activities

1. Verify Line Clearance Certificate from QA before starting labeling operations.
2. Collect labels from the packaging material store against requisition.
3. Check label details: Product Name, Batch No., Mfg. Date, Exp. Date, MRP, and Regulatory Warnings.
4. Ensure that label roll orientation matches with labeling machine requirements.

5.2 Setup and Labeling Process

1. Load the correct label roll into the automatic/semi-automatic labeling machine.
2. Adjust sensor sensitivity for label gap detection and alignment.
3. Perform a trial run with 5–10 dummy tubes/jars and inspect for placement accuracy and clarity.
4. Initiate labeling only after QA clearance.
5. Feed tubes or jars into the labeling machine and monitor output.
6. In case of manual labeling, apply the label horizontally without air bubbles or misalignment.
7. Ensure labels are stuck uniformly without wrinkles or folds.

5.3 Labeling Inspection and Reconciliation

1. Perform random in-process checks at regular intervals (every 30 minutes) for label position, clarity, and accuracy.
2. Record results in the Labeling IPC Log Sheet (Annexure-1).
3. At the end of the batch, count the number of tubes/jars labeled and tally against the label issuance record.
4. Return excess unused labels to the store with documentation.
5. Destroy rejected/damaged labels in the presence of QA with proper documentation.

6. Abbreviations

• IPC: In-Process Control
• QA: Quality Assurance
• MRP: Maximum Retail Price
• SOP: Standard Operating Procedure

7. Documents

1. Label Issuance Record
2. Line Clearance Certificate
3. Labeling IPC Log Sheet – Annexure-1
4. Label Reconciliation Log

8. References

• GMP Guidelines – WHO TRS 961 Annex 3
• Schedule M – Labeling and Packaging Section

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: Labeling IPC Log Sheet

Time	Sample Size	Label Text Correctness	Positioning Accuracy	Comments	Checked By
	5 Units
	5 Units
	5 Units

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
02/06/2022	1.0	Initial version	New SOP creation	QA Head
02/06/2025	2.0	Added clarity checks and manual labeling section	Annual Review	QA Head