Tablets: SOP for Visual Defect Analysis of Finished Tablets – V 2.0

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Tablets: SOP for Visual Defect Analysis of Finished Tablets – V 2.0

Standard Operating Procedure for Visual Defect Analysis of Finished Tablets

Department Quality Control
SOP No. SOP/TAB/120/2025
Supersedes SOP/TAB/120/2022
Page No. Page 1 of 5
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish the procedure for conducting a visual inspection of finished tablets to identify any defects in appearance, coating, or shape that may affect product quality and compliance with specifications.

2. Scope

This SOP applies to the visual inspection of finished tablets post-manufacturing to ensure they meet the required quality standards, including uniformity in shape, color, and coating integrity.

3. Responsibilities

  • Quality Control (QC): Responsible for performing the visual defect analysis and documenting any defects found during the inspection.
  • Quality Assurance (QA): Ensures that the visual inspection is performed according to this SOP and reviews the results to confirm compliance with product specifications and regulatory standards.
  • Laboratory Personnel: Responsible for inspecting the tablets and documenting any visible defects such as chips, cracks, discoloration, or coating inconsistencies.

4. Accountability

The QC Manager is accountable for ensuring that visual inspection is conducted accurately and consistently. The QA Manager is responsible for reviewing and approving inspection records to ensure compliance with regulatory and quality standards.

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5. Procedure

5.1 Sample Preparation

  1. Obtain a representative sample of finished tablets from the batch to be tested (usually at least 100 tablets).
  2. Ensure that the sample is free from any contamination, damage, or foreign material.
  3. Place the tablets on a clean, non-reflective surface, ensuring good lighting conditions for inspection.

5.2 Visual Inspection

  1. Examine the tablets for any visible defects, such as:
    • Chips or cracks in the tablet surface
    • Discoloration or uneven color
    • Inconsistent or damaged coating
    • Irregular shape or size
    • Surface contamination
  2. Use magnification (e.g., a loupe or magnifying glass) if necessary to detect small defects or irregularities.
  3. Count the number of defective tablets observed during the inspection process.
  4. Document any defects found, including the type of defect, the number of affected tablets, and the severity of the defect (minor, moderate, or severe).

5.3 Inspection Criteria

  1. The following criteria must be met for the batch to pass the visual inspection:
    • No visible defects should be present in more than 1% of the inspected tablets.
    • No more than 0.5% of the tablets should have severe defects (e.g., large cracks, significant discoloration).
    • All tablets should have a uniform shape, size, and coating without any significant irregularities.
  2. If defects exceed the specified limits, the batch is considered non-compliant and must be rejected or investigated further.
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5.4 Documentation

  1. Record the number of tablets inspected, the number of defective tablets found, and the type of defects in the batch record (Annexure-2).
  2. Document the corrective actions taken if defects are found, including whether the batch was reprocessed or rejected.
  3. Ensure all inspection records are signed and dated by the responsible personnel and reviewed by QA for compliance.

5.5 Acceptance Criteria

  1. For the batch to be accepted, the following criteria should be met:
    • No more than 1% defective tablets
    • No more than 0.5% severe defects
    • All tablets must have uniform appearance, with acceptable coating, color, and shape
  2. If defects exceed the above thresholds, the batch must be rejected or investigated, and corrective actions should be documented in the deviation report (Annexure-1).

5.6 Post-Inspection Actions

  1. Ensure that the defective tablets, if any, are segregated and properly disposed of according to the company’s waste disposal procedures.
  2. If the batch passes the inspection, release it for packaging or further processing.
  3. Ensure that all necessary adjustments are made to the manufacturing process if recurring defects are observed.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

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

8. References

  • USP <701> – Disintegration Testing
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • European Pharmacopoeia (EP) – Tablets and Tablet Coatings

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 Visible cracks in 2% of the tablets Batch rejected and reprocessed Jane Smith

Annexure-2: Batch Record

Batch Number Tablets Inspected Defective Tablets Defect Type Action Taken
Batch 001 100 2 Cracks in coating Batch rejected

Revision History:

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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 and defect classification Improved quality standards QA Head
Tablet Manufacturing V2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , , , ,