SOP Guide for Pharma

Tablets: SOP for Layer Thickness Monitoring in Multi-Layer Tablets – V 2.0

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Tablets: SOP for Layer Thickness Monitoring in Multi-Layer Tablets – V 2.0

Standard Operating Procedure for Layer Thickness Monitoring in Multi-Layer Tablets

Department Quality Control
SOP No. SOP/TAB/134/2025
Supersedes SOP/TAB/134/2022
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 monitoring the layer thickness of multi-layer tablets during production to ensure uniformity and meet the required specifications for tablet performance and quality.

2. Scope

This SOP applies to the monitoring of layer thickness in multi-layer tablets during the manufacturing process. It ensures that each layer of the tablet is within the specified thickness range, contributing to consistent tablet quality.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that layer thickness measurements are taken correctly and consistently throughout production. The QA Manager is responsible for reviewing the results and ensuring compliance with the required quality standards.

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5. Procedure

5.1 Layer Thickness Measurement

  1. Measure the thickness of the tablet layers at regular intervals during the compression process.
  2. Use precision calipers or other appropriate measuring devices to measure the thickness of each layer in the multi-layer tablet. Each layer must be measured at multiple points around the tablet to ensure uniformity.
  3. Record the measurement of each layer separately, noting the average thickness and any variations.
  4. The thickness of each layer should be within the specified tolerance range, typically ± 0.05 mm, depending on the product specifications.

5.2 Sampling

  1. For every batch, collect a representative sample of tablets to measure the layer thickness. Typically, collect 10 tablets per batch to ensure accurate representation.
  2. For multi-layer tablets, measure both the individual layers and the overall tablet thickness to verify the correct formation of all layers.
  3. Ensure that the sample is taken from different locations (top, middle, and bottom of the batch) to evaluate consistency across the entire batch.

5.3 Monitoring Frequency

  1. Monitor the layer thickness at regular intervals during the compression process. This could be after every 100 tablets or at specific stages of production (e.g., after each layer is applied).
  2. If the layer thickness consistently falls within the specified tolerance, monitoring can be reduced to once every 500 tablets. However, if there is a variation in the results, increase the monitoring frequency to every 50 tablets.
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5.4 Corrective Actions

  1. If the layer thickness falls outside the specified tolerance range, take corrective actions such as adjusting the compression force, modifying the filling volume, or altering the tablet press settings.
  2. After making adjustments, re-sample and re-test the tablets to ensure that the layer thickness is within specification.
  3. Document all corrective actions taken and the results of re-sampling in the batch record (Annexure-2).

5.5 Documentation

  1. Record the layer thickness measurements for each tablet sampled, including the average thickness and the individual layer measurements, in the batch record (Annexure-2).
  2. Document any deviations from the specified thickness range and the corrective actions taken in the deviation report (Annexure-1).
  3. Ensure that all records are signed, dated, and reviewed by QA for compliance with the required specifications.

5.6 Acceptance Criteria

  1. The thickness of each layer should fall within the specified tolerance limits, typically ± 0.05 mm, unless otherwise specified for a specific product.
  2. If the layer thickness exceeds the allowable tolerance, the batch may need to be rejected or reworked.

5.7 Post-Production Actions

  1. Once the layer thickness has been confirmed to meet specifications, proceed with the next steps of tablet processing, such as coating, drying, and packaging.
  2. Ensure that the equipment used for measuring layer thickness is calibrated regularly and maintained according to the preventive maintenance schedule.
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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 Layer thickness exceeded tolerance limit Adjusted compression force and granule size John Doe

Annexure-2: Batch Record

Sample Number Layer Thickness Result Action Taken
Sample 1 Pass (Layer thickness within tolerance) 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 layer thickness monitoring process Improved quality standards QA Head
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