SOP Guide for Pharma

Tablets: SOP for Final Inspection of Coated Tablets Before Packing – V 2.0

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Tablets: SOP for Final Inspection of Coated Tablets Before Packing – V 2.0

Standard Operating Procedure for Final Inspection of Coated Tablets Before Packing

Department Tablet
SOP No. SOP/TAB/203/2025
Supersedes SOP/TAB/203/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP outlines the procedure for conducting the final inspection of coated tablets before they are packed. It ensures that the coated tablets meet the required quality standards and are free from defects, contamination, or any other issues that could affect their quality or safety.

2. Scope

This SOP applies to all coated tablets produced in the tablet manufacturing department. It covers the inspection process from the completion of the coating process until the tablets are ready for packaging.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the final inspection is conducted according to this SOP. The Production Manager is responsible for ensuring the timely transfer of the coated tablets to the QC inspection area.

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5. Procedure

5.1 Preparation for Final Inspection

  1. Ensure that the coated tablets are transferred from the coating machine to the inspection area in a clean and organized manner, free from any contamination.
  2. Verify that the correct batch of coated tablets is available for inspection, and ensure that the batch records and production logs are up to date (Annexure-1).
  3. Ensure that all necessary inspection tools and equipment (e.g., magnifying glass, calipers, sampling containers) are available and in good condition for the inspection process.

5.2 Inspection of Coated Tablets

  1. Visually inspect a representative sample of coated tablets for any visible defects such as chips, cracks, discoloration, or any coating irregularities.
  2. Check the uniformity of the coating, ensuring that the tablets have an even coat without peeling or flaking. Look for any signs of over-coating or under-coating (Annexure-2).
  3. Ensure that the color of the tablets matches the specified color requirements and that no foreign particles are present on the tablets.
  4. Measure the thickness of the coating on the tablets using calipers or other appropriate measuring tools. Ensure that the coating thickness falls within the acceptable range specified in the batch records (Annexure-3).
  5. Perform a hardness test on a representative sample of the tablets to ensure that they are within the specified hardness range, as this can be affected by the coating process.
  6. Conduct a friability test on a representative sample to ensure that the tablets do not break or chip during normal handling.

5.3 Documentation of Inspection Results

  1. Record all inspection results, including visual inspection, coating thickness, hardness, and friability test results, in the Final Inspection Log (Annexure-4).
  2. If any defects or deviations from the specifications are identified during the inspection, document them immediately in the deviation log and notify the QA team for further investigation.
  3. Ensure that all inspection records are signed by the responsible QC personnel and that the batch number, inspection date, and time are clearly recorded.
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5.4 Acceptance or Rejection of Coated Tablets

  1. If the coated tablets pass the inspection criteria, approve them for packaging by updating the batch records and marking the batch as ready for packaging (Annexure-5).
  2. If any tablets fail the inspection, segregate the rejected tablets, and investigate the cause of the defects. Ensure that corrective actions are documented, and initiate a CAPA process if necessary (Annexure-6).
  3. Rejected tablets must be properly disposed of or sent for reprocessing in accordance with the company’s waste disposal and rework procedures.

5.5 Final Approval for Packing

  1. Once the batch passes the final inspection, sign off the inspection report and prepare the tablets for the packaging process.
  2. Ensure that the packaging team receives the inspected batch along with the appropriate inspection and batch documentation.
  3. Monitor the transition of the batch from inspection to packaging to ensure that all documentation is complete and accurate.

5.6 Cleaning and Maintenance of Inspection Equipment

  1. After completing the final inspection, clean all inspection equipment, including magnifying glasses, calipers, and measuring tools, to ensure they remain free from contamination.
  2. Check that all equipment is properly stored and maintained for future use.

6. Abbreviations

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7. Documents

  1. Batch Records (Annexure-1)
  2. Coating Inspection Log (Annexure-2)
  3. Coating Thickness Measurement Log (Annexure-3)
  4. Final Inspection Log (Annexure-4)
  5. Inspection Approval and Rejection Report (Annexure-5)
  6. CAPA Documentation (Annexure-6)

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 Records

Batch Number Coating Process Inspection Date Inspector Name
Batch-12345 Coating Process-01 01/03/2026 John Doe

Annexure-2: Coating Inspection Log

Sample ID Inspection Type Result Remarks
Sample-123 Visual Inspection Pass No defects

Annexure-3: Coating Thickness Measurement Log

Sample ID Measured Thickness Target Thickness Deviation
Sample-123 0.12mm 0.12mm None

Annexure-4: Final Inspection Log

Batch Number Inspection Result Inspector Name Approval Status
Batch-12345 Pass Jane Smith Approved

Annexure-5: Inspection Approval and Rejection Report

Batch Number Inspection Status Action Taken Comments
Batch-12345 Approved Move to packing No defects found

Annexure-6: CAPA Documentation

CAPA ID Action Description Completion Date Responsible Person
CAPA-001 Investigated and resolved coating issues 01/04/2026 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 procedures Improved defect detection process QA Head
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