are correct and verified before starting the activity.

QA Officer: Verifies label reconciliation and checks correctness during line clearance and in-process checks.

4. Accountability

Head – Manufacturing is accountable for ensuring that the procedure is implemented and maintained in compliance with regulatory and GMP requirements.

5. Procedure

5.1 Label Receipt and Verification

1. Receive printed labels and coding information from the Label Control Store along with the Label Issue Slip.
2. Verify correctness of product name, strength, batch number, manufacturing and expiry dates, license number, barcode (if applicable), and other regulatory information.
3. Ensure the quantity received matches the requirement as per the batch size and packing plan.

5.2 Equipment and Material Preparation

1. Ensure that the labeling and coding equipment is clean, functional, and calibrated.
2. Set up inkjet printer or thermal transfer printer with appropriate ink or ribbon as per equipment SOP.
3. Prepare a “Labeling and Coding Area” with adequate lighting and cleanliness.

5.3 Line Clearance

1. QA performs line clearance before beginning labeling and coding activity.
2. Ensure removal of all previous batch materials, labels, and documents from the work area.
3. Record line clearance in the Line Clearance Checklist – Annexure-1.

5.4 Labeling and Coding Process

1. Label each primary container (tube, jar, etc.) with the correct printed label.
2. Ensure alignment, adhesion, and legibility of the label on each container.
3. Code the containers with required information using a validated printing device.
4. Perform periodic checks every 30 minutes or 100 units (whichever is earlier) to confirm label integrity and coding accuracy.

5.5 Label Reconciliation

1. Record number of labels issued, used, and returned/rejected in the Label Reconciliation Log – Annexure-2.
2. All unused or rejected labels must be returned to the Label Control Store with proper documentation.

5.6 Handling Deviations

1. If any mislabeled or miscoded unit is found, immediately segregate and investigate.
2. Notify QA and document the deviation using Deviation Report Form – Annexure-3.
3. Only QA shall decide whether to reprocess, re-label, or destroy the affected units.

6. Abbreviations

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

7. Documents

1. Label Issue Slip
2. Line Clearance Checklist – Annexure-1
3. Label Reconciliation Log – Annexure-2
4. Deviation Report Form – Annexure-3

8. References

• Schedule M: Good Manufacturing Practices and Requirements of Premises
• 21 CFR Part 211 – Subpart G: Packaging and Labeling Control

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 Checklist

Item Checked	Status (Yes/No)	Remarks	Checked By
Previous batch materials removed
Equipment cleaned
Correct labels available

Annexure-2: Label Reconciliation Log

Batch No.	Labels Issued	Labels Used	Labels Returned	Rejected	Verified By (QA)

Annexure-3: Deviation Report Form

Date	Batch No.	Description of Deviation	Immediate Action Taken	Investigated By	QA Decision

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
04/04/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Updated label reconciliation and deviation handling steps	Annual review	QA Head