Tablets: SOP for Ensuring Batch Code Legibility on Packaging – V 2.0

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Tablets: SOP for Ensuring Batch Code Legibility on Packaging – V 2.0

Standard Operating Procedure for Ensuring Batch Code Legibility on Packaging

Department Tablet
SOP No. SOP/TAB/239/2025
Supersedes SOP/TAB/239/2022
Page No. Page 1 of 5
Issue Date 01/04/2026
Effective Date 06/04/2026
Review Date 01/04/2027

1. Purpose

The purpose of this SOP is to establish a systematic procedure for ensuring that batch codes are legible and correctly printed on tablet packaging. This ensures traceability, compliance with regulatory requirements, and product safety.

2. Scope

This SOP applies to all tablet products that require batch coding for identification, tracking, and regulatory purposes. It covers all stages of packaging, from label printing to final product inspection.

3. Responsibilities

  • Production Manager: Ensures the batch code printing process follows the SOP and addresses any issues related to legibility or accuracy of batch codes on packaging.
  • Packaging Operator: Operates the packaging equipment, ensuring correct batch code application during packaging, and performs routine checks to ensure legibility.
  • Quality Control (QC) Inspector: Verifies the legibility of batch codes on packaging and ensures compliance with regulatory and internal standards.
  • Maintenance Personnel: Maintains and calibrates batch code printing equipment to prevent issues related to print clarity or misalignment.
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4. Accountability

The Production Manager is accountable for ensuring compliance with this SOP. The QC department is responsible for verifying the legibility of batch codes during the packaging process.

5. Procedure

5.1 Preparation for Batch Code Printing

  1. Ensure that the packaging equipment is clean and properly set up for batch code printing (Annexure-1).
  2. Verify that the correct batch code is available for printing, matching the product batch and corresponding packaging requirements (Annexure-2).
  3. Check that the batch code printing machine is calibrated and ready for operation (Annexure-3).

5.2 Batch Code Printing Process

  1. Load the packaging material onto the production line, ensuring that it is aligned properly (Annexure-4).
  2. Start the batch code printing process and monitor the output for print quality. Ensure that the batch code is clear, legible, and free from smudging (Annexure-5).
  3. Ensure the batch code is printed in the correct position on the packaging (e.g., on the side of a blister pack, on the bottom of a bottle) (Annexure-6).
  4. Monitor the print quality regularly and stop the line if any printing issues, such as unclear or misaligned codes, are detected (Annexure-7).

5.3 Verification of Batch Code Legibility

  1. After printing, perform a visual inspection to verify that the batch code is legible and placed correctly on each unit of packaging (Annexure-8).
  2. Verify that the batch code is printed without any smudging, fading, or misalignment. Check the print consistency across multiple units of packaging (Annexure-9).
  3. If any illegible batch codes are found, document the issue and stop the production line to rework or discard affected units (Annexure-10).
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5.4 Corrective Actions for Batch Code Issues

  1. If any defects are found, immediately stop the packaging line and investigate the cause of the issue, such as printer malfunction or material issues (Annexure-11).
  2. Recalibrate the printer or replace any faulty equipment and restart the printing process (Annexure-12).
  3. Perform a reprint if necessary, ensuring that the batch code is correctly applied to the remaining units (Annexure-13).
  4. Segregate any affected products and label them as “Rejected” if they do not meet the required batch code legibility (Annexure-14).

5.5 Final Inspection and Packaging

  1. Once the batch codes are verified for legibility, complete the rest of the packaging process, including sealing and labeling (Annexure-15).
  2. Perform a final quality check to ensure all packaging meets the required specifications and that the batch codes are legible (Annexure-16).
  3. Complete the batch record and submit the batch for QA review and release (Annexure-17).
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • GMP: Good Manufacturing Practice

7. Documents

  1. Batch Code Printing Log (Annexure-1)
  2. Batch Code Verification Log (Annexure-2)
  3. Printer Calibration Log (Annexure-3)
  4. Packaging Alignment Log (Annexure-4)
  5. Batch Code Printing Inspection Log (Annexure-5)
  6. Batch Code Placement Log (Annexure-6)
  7. Print Quality Log (Annexure-7)
  8. Legibility Verification Log (Annexure-8)
  9. Batch Code Consistency Log (Annexure-9)
  10. Defective Batch Code Log (Annexure-10)
  11. Corrective Action Log (Annexure-11)
  12. Printer Recalibration Log (Annexure-12)
  13. Reprint Log (Annexure-13)
  14. Rejected Product Log (Annexure-14)
  15. Packaging Completion Log (Annexure-15)
  16. Final Quality Check Log (Annexure-16)
  17. Batch Record (Annexure-17)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
  • USP <1079> – Good Storage and Distribution Practices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Code Printing Log

Batch Number Printing Date Operator Print Quality
Batch 12345 01/04/2026 John Doe Pass

Annexure-2: Batch Code Verification Log

Batch Number Verification Date Verified By Verification Result
Batch 12345 01/04/2026 Jane Smith Pass
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