SOP Guide for Pharma

Tablets: SOP for Visual Inspection of Coated Tablets for Defects – V 2.0

Auditor

Tablets: SOP for Visual Inspection of Coated Tablets for Defects – V 2.0

Standard Operating Procedure for Visual Inspection of Coated Tablets for Defects

Department Tablet
SOP No. SOP/TAB/150/2025
Supersedes SOP/TAB/150/2022
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 conducting a visual inspection of coated tablets for defects to ensure the tablets meet the required quality standards before packaging.

2. Scope

This SOP applies to the visual inspection process for coated tablets during the final stages of tablet production to ensure they are free from defects such as chips, cracks, discoloration, or coating inconsistencies.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the visual inspection of coated tablets is performed regularly and in compliance with the SOP. The QA Manager reviews the inspection results and approves any corrective actions or deviations.

See also  Tablets: SOP for Granule Moisture Content Testing Before Compression - V 2.0

5. Procedure

5.1 Preparation for Inspection

  1. Ensure that the inspection area is well-lit and clean to facilitate the accurate identification of defects.
  2. Place the coated tablets on an inspection tray or conveyor belt for easy inspection by the operator.
  3. Verify that all inspection equipment, such as magnifying glasses or automated inspection systems, are properly calibrated and ready for use.

5.2 Visual Inspection Method

  1. Inspect the tablets for the following common defects:
    • Chips or cracks in the coating
    • Inconsistent or uneven coating thickness
    • Discoloration or staining
    • Visible foreign particles embedded in the coating
    • Non-uniform tablet shapes
  2. Inspect a representative sample from each batch of tablets. The sample size should be in accordance with the established sampling plan (e.g., 100 tablets per batch).
  3. For automated visual inspection, ensure that the machine settings are correct, and the tablets are passing through the system as intended. Review any flagged tablets for defects manually.

5.3 Documentation of Inspection Results

  1. Record all observations in the batch record (Annexure-2), noting the type and number of defects found, if any.
  2. If defects are found, document the nature and extent 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 a root cause investigation.
See also  Tablets: SOP for Tablet Drying Process - V 2.0

5.4 Corrective Actions

  1. If defects are found, take corrective actions such as adjusting the coating process, reformulating the coating solution, or modifying the coating machine settings.
  2. Reinspect the tablets after corrective actions have been implemented to ensure the defects have been resolved.
  3. Document any corrective actions taken and verify their effectiveness through further inspection or testing.

5.5 Acceptance Criteria

  1. The batch of tablets is considered acceptable if no more than 1% of the tablets have defects that exceed the predetermined threshold (e.g., no more than 5 tablets out of a 100 tablet sample).
  2. Defects such as minor discoloration or slight coating imperfections that do not affect the functionality or safety of the tablet are considered acceptable within predefined limits.

5.6 Post-Inspection Actions

  1. If the batch passes the inspection, proceed with the next steps in tablet production, such as packaging and labeling.
  2. If the batch fails, investigate the root cause of the defects and take necessary corrective actions. If the batch cannot be reworked to meet standards, it should be rejected and documented accordingly.
See also  Tablets: SOP for Disintegration Testing for Immediate Release Tablets - V 2.0

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 Coating imperfections found during visual inspection Adjusted coating parameters and reworked the batch John Doe

Annexure-2: Batch Record

Sample Number Defect Type Defect Count Action Taken
Sample 1 Minor discoloration 1 Accepted
Sample 2 Crack in coating 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 inspection criteria Improved defect identification process QA Head
Exit mobile version