the Gel Manufacturing department.

3. Responsibilities

• Packaging Operator: Operate the batch coding machine and ensure correct settings.
• QA Personnel: Verify coded information and record verification results.
• Maintenance Engineer: Assist in setup, calibration, and maintenance of coding equipment.
• Packaging Supervisor: Review records and ensure compliance throughout the operation.

4. Accountability

The Head – Manufacturing is accountable for the implementation of this SOP and compliance with batch coding accuracy across all gel packaging lines.

5. Procedure

5.1 Preparation

1. Verify the coding machine (inkjet or embossing) is clean, functional, and properly calibrated.
2. Ensure availability of coding ink or printing foil ribbons as per the coding machine type.
3. Cross-check batch details from the Batch Manufacturing Record (BMR).
4. Prepare a trial sample with the batch code, manufacturing date, expiry date, and MRP (if applicable) printed.
5. Send trial sample for QA verification and approval before initiating coding operation.

5.2 Coding Operation

1. Start the coding operation only after QA clearance of the sample code.
2. Position the packaged gel containers properly to ensure uniform placement of the printed code.
3. Monitor the clarity and completeness of print on each unit.
4. Perform periodic checks (every 30 minutes or every 1000 units) to ensure consistency of print quality and content.
5. Record deviations, if any, and halt operations for rectification as necessary.

5.3 Information to be Coded

1. Product Name
2. Batch Number
3. Manufacturing Date (MM/YYYY)
4. Expiry Date (MM/YYYY)
5. MRP (if applicable)

5.4 Post-Coding Activities

1. Ensure no units without batch codes proceed for secondary packaging.
2. Segregate and destroy all incorrectly coded units under QA supervision.
3. Record the coding operation in the Batch Coding Logbook (Annexure-2).
4. Affix coded samples with inspection and release status for QA reference.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• MRP: Maximum Retail Price

7. Documents

1. Batch Coding Trial Approval Form – Annexure-1
2. Batch Coding Logbook – Annexure-2
3. Batch Manufacturing Record
4. QA Line Clearance Checklist

8. References

• Schedule M – Labeling and Packaging Requirements
• Internal SOP on Labeling Control
• WHO GMP Guide – Good Documentation Practices

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: Batch Coding Trial Approval Form

Batch Number
Product Name
Trial Code Date
Code Content Verified	☐ Yes ☐ No
Print Clarity Verified	☐ Yes ☐ No
QA Verified By
Date

Annexure-2: Batch Coding Logbook

Date	Batch No.	Start Time	End Time	Total Units	Defects Observed	Remarks	Operator

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP implementation	QA Head
02/06/2025	2.0	Updated batch coding requirements and log formats	Annual review	QA Head