SOP Guide for Pharma

Tablets: SOP for Tablet Marking Inspection During Compression – V 2.0

Auditor

Tablets: SOP for Tablet Marking Inspection During Compression – V 2.0

Standard Operating Procedure for Tablet Marking Inspection During Compression

Department Tablet
SOP No. SOP/TAB/152/2025
Supersedes SOP/TAB/152/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for performing tablet marking inspection during the compression process to ensure that the markings on the tablets meet the required specifications for identification and branding.

2. Scope

This SOP applies to the inspection of tablet markings during the compression stage of tablet manufacturing, ensuring proper and consistent markings on all tablets.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that tablet markings are inspected regularly during compression. The QA Manager ensures the marking inspection process is compliant with the SOP and approves any corrective actions or deviations.

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5. Procedure

5.1 Preparation for Inspection

  1. Ensure the inspection area is well-lit and clean to facilitate accurate inspection of tablet markings.
  2. Verify that all inspection tools, such as magnifying glasses or automated tablet marking inspection systems, are properly calibrated and ready for use.
  3. Confirm that the compression machine is properly set up to apply the required tablet markings according to the design specifications.

5.2 Marking Inspection Method

  1. Inspect each tablet for the following:
    • Legibility of the marking (e.g., text, logo)
    • Consistency of the marking (e.g., uniformity of depth, size, and location)
    • Presence of any defects such as smudging, incomplete markings, or double markings
    • Correct positioning of the marking on the tablet surface
  2. Inspect a representative sample from each batch of tablets. The sample size should be defined in the sampling plan (e.g., 100 tablets per batch).
  3. If using an automated inspection system, verify that it is functioning correctly and flagging any tablets with defective markings.

5.3 Documentation of Inspection Results

  1. Document the results of the marking inspection in the batch record (Annexure-2), noting the type and number of defects found, if any.
  2. If defects are found, document the nature of the defects, including whether they are isolated occurrences or affect the entire batch.
  3. If defects exceed acceptable limits, generate a deviation report (Annexure-1) and initiate an investigation.
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5.4 Corrective Actions

  1. If defects are found, take corrective actions such as adjusting the compression machine settings or modifying the tablet design or marking process.
  2. After corrective actions are taken, perform further inspection to verify that the defects have been resolved.
  3. Document any corrective actions taken and verify their effectiveness through further inspections or tests.

5.5 Acceptance Criteria

  1. The batch of tablets is considered acceptable if the marking defects do not exceed the predefined threshold (e.g., no more than 2% of the tablets from the sample show defects).
  2. Minor defects, such as slight smudging that does not affect tablet identification, may be acceptable within predefined limits.

5.6 Post-Inspection Actions

  1. If the batch passes the inspection, proceed with further tablet manufacturing steps, such as drying, coating, or packaging.
  2. If the batch fails, perform a root cause analysis, modify the marking process, and re-inspect until the correct marking quality is achieved.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Inconsistent tablet markings during compression Adjusted compression machine settings and rechecked marking alignment John Doe

Annexure-2: Batch Record

Sample Number Marking Defect Type Defect Count Action Taken
Sample 1 Smudged marking 1 Accepted
Sample 2 Missing marking 0 Accepted

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated marking inspection criteria Improved defect identification process QA Head
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