SOP Guide for Pharma

Tablets: SOP for Core Tablet Inspection Before Film Coating – V 2.0

Auditor

Tablets: SOP for Core Tablet Inspection Before Film Coating – V 2.0

Standard Operating Procedure for Core Tablet Inspection Before Film Coating

Department Tablet
SOP No. SOP/TAB/143/2025
Supersedes SOP/TAB/143/2022
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 inspecting core tablets before the application of the film coating, ensuring that the core tablets meet the required quality specifications for coating application.

2. Scope

This SOP applies to the inspection of core tablets before they are processed in the film coating machine, ensuring that they are free from defects and meet the necessary criteria for successful coating.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the core tablet inspection process is followed and that any defects are addressed before the coating process. The QA Manager is responsible for reviewing and approving inspection results.

5. Procedure

5.1 Tablet Sampling for Inspection

  1. From the batch of core tablets, select a representative sample of tablets, typically 10 tablets from different locations within the batch (top, middle, and bottom) to ensure uniformity.
  2. Ensure that the sample size is sufficient to detect any potential defects or inconsistencies in the batch.
  3. Weigh the tablets, if necessary, and ensure they meet the required weight specifications before proceeding to the inspection phase.
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5.2 Visual Inspection

  1. Perform a visual inspection of each selected tablet for common defects, such as cracks, chips, surface irregularities, or improper tablet shape.
  2. Ensure that the tablet’s edges are smooth, and the surface is free from visible marks, stains, or foreign particles.
  3. Examine the tablet for uniformity in size and shape. If any tablet does not meet the specified dimensions, it should be discarded or marked for reprocessing.
  4. If any tablets exhibit visible defects, remove them from the batch, and notify the production team to address the root cause of the defect.

5.3 Hardness and Friability Testing (if applicable)

  1. Perform hardness and friability tests on a sample of tablets to ensure that they are mechanically stable enough for coating. These tests should be performed according to established specifications for the tablet formulation.
  2. If tablets do not meet the hardness or friability specifications, the batch should be investigated for potential process issues, such as improper compression force or inappropriate excipient selection.

5.4 Surface Moisture Check

  1. Ensure that the tablets have a proper surface moisture level suitable for the coating process. Excessive moisture may affect the adhesion of the coating material, while too little moisture may result in poor tablet bonding.
  2. If necessary, perform moisture content testing on the tablets to confirm that they fall within the desired range, as specified for the specific formulation.
See also  Tablets: SOP for Weight Variation Control in Extended Release Tablets - V 2.0

5.5 Cleaning and Handling

  1. Ensure that the core tablets are handled with care during the inspection process to avoid introducing any contamination or damage to the tablet surface.
  2. If contamination is detected (e.g., dust, particles), gently clean the surface using a soft, lint-free cloth or air blower, ensuring that no additional defects are introduced.
  3. Only pass clean, intact, and defect-free tablets to the coating stage of the production process.

5.6 Documentation

  1. Document the results of the core tablet inspection in the batch record (Annexure-2), including details of any defects found, the number of defective tablets removed, and any corrective actions taken.
  2. If any defects are identified that affect a significant portion of the batch, create a deviation report (Annexure-1), detailing the cause of the issue and the actions taken to resolve it.
  3. Ensure all inspection data is signed, dated, and reviewed by QA to confirm compliance with the specifications and quality standards.

5.7 Acceptance Criteria

  1. Core tablets should be free from any cracks, chips, or surface defects that could interfere with the coating process or affect tablet quality.
  2. The tablets should meet the size and weight specifications, and the moisture content should fall within the acceptable range for the coating process.
  3. If the core tablets do not meet the specified criteria, they must not be processed in the film coating machine and should either be rejected or sent for reprocessing.
See also  Tablets: SOP for High-Pressure Homogenization Analysis for Coated Tablets - V 2.0

5.8 Post-Inspection Actions

  1. If the batch passes the inspection, it should be transferred to the coating department for further processing.
  2. Ensure that the inspection results are recorded and retained in the batch record, as part of the traceability and quality assurance process.

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 Core tablet defects (chips) found during inspection Removed defective tablets and adjusted compression settings John Doe

Annexure-2: Batch Record

Sample Number Tablet Size/Shape Defects Found Action Taken
Sample 1 8 mm round No defects 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 tablet inspection process Improved inspection methods QA Head
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