SOP Guide for Pharma

Tablets: SOP for Visual Inspection of Tablet Coating Uniformity – V 2.0

Auditor

Tablets: SOP for Visual Inspection of Tablet Coating Uniformity – V 2.0

Standard Operating Procedure for Visual Inspection of Tablet Coating Uniformity

Department Quality Control
SOP No. SOP/TAB/103/2025
Supersedes SOP/TAB/103/2022
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 visually inspecting the uniformity of tablet coatings, ensuring that the coating process is consistent and meets product specifications for appearance and quality.

2. Scope

This SOP applies to the visual inspection of coated tablets during the manufacturing process. It covers the identification of coating defects, color uniformity, and any other coating-related issues.

3. Responsibilities

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4. Accountability

The QC Manager is accountable for overseeing the visual inspection process and ensuring that the coated tablets meet the required standards. The QA Manager is responsible for approving the inspection results before the release of the product.

5. Procedure

5.1 Inspection Preparation

  1. Ensure that the tablet coating equipment has been calibrated and is functioning correctly before starting the inspection process.
  2. Prepare the inspection area by ensuring proper lighting, a clean environment, and any necessary tools, such as magnifying lenses or inspection trays.
  3. Collect a representative sample of coated tablets from the batch, ensuring that the sample size is adequate to evaluate coating uniformity (usually 10–20 tablets, or as specified in the batch record).

5.2 Visual Inspection Process

  1. Examine the tablets for overall coating appearance. Check for uniformity in coating color, thickness, and surface finish.
  2. Inspect each tablet for coating defects such as:
    • Uneven coating
    • Peeling or cracking
    • Spotting or discoloration
    • Air bubbles or blisters
    • Chipping or other physical damage to the coating
  3. If defects are identified, record the findings and segregate the defective tablets for further evaluation and investigation.
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5.3 Acceptance Criteria

  1. Coating should be uniform across the entire surface of the tablet, without visible defects such as cracks, chips, or peeling.
  2. Color consistency should be within acceptable limits, with no significant variations between individual tablets or within different areas of a tablet.
  3. Any defects or variations that fall outside of the established acceptable limits should be documented, and corrective actions should be implemented (Annexure-1).

5.4 Documentation and Record-Keeping

  1. Document the visual inspection results, including any defects observed, corrective actions taken, and the number of defective tablets found, in the batch record (Annexure-1).
  2. Ensure that all inspection records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
  3. Maintain a log of any corrective actions taken during the inspection process, along with the outcome of rework or corrective measures.

5.5 Post-Inspection Actions

  1. Segregate defective tablets from the acceptable batch and follow the established procedure for investigating and resolving coating defects.
  2. If necessary, perform additional tests or rework the coating process to meet uniformity standards and re-inspect the tablets.

6. Abbreviations

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7. Documents

  1. Batch Record (Annexure-1)
  2. Defective Tablet Report (Annexure-2)

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: Batch Record

Batch Number Tablet Sample Coating Uniformity Defect Type Corrective Action
Batch 001 Tablet Sample Uniform None Pass

Annexure-2: Defective Tablet Report

Defect Date Batch Number Defect Description Corrective Action Taken Responsible Person
15/12/2025 Batch 001 Cracking in coating Reworked coating process John Doe

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 Process Refined defect categorization QA Head
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