SOP Guide for Pharma

Tablets: SOP for In-Process Hardness Monitoring in Tablets – V 2.0

Auditor

Tablets: SOP for In-Process Hardness Monitoring in Tablets – V 2.0

Standard Operating Procedure for In-Process Hardness Monitoring in Tablets

Department Quality Control
SOP No. SOP/TAB/122/2025
Supersedes SOP/TAB/122/2022
Page No. Page 1 of 5
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for monitoring tablet hardness during the manufacturing process, ensuring that the final product meets the specified hardness requirements.

2. Scope

This SOP applies to the monitoring of tablet hardness during the compression process, ensuring that tablets meet the required hardness specifications for stability, quality, and ease of handling.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that in-process hardness testing is performed consistently and accurately. The QA Manager is responsible for reviewing the test results to confirm compliance with regulatory and internal standards.

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5. Procedure

5.1 Sample Collection

  1. During the tablet compression process, collect a representative sample of tablets at regular intervals, typically every 15 minutes or according to the batch record.
  2. The sample size should consist of at least 10 tablets to ensure reliable results.

5.2 Hardness Measurement

  1. Measure the hardness of each tablet using a calibrated hardness tester (e.g., a tablet hardness tester that measures the force required to break the tablet).
  2. Ensure that the tester is properly calibrated and zeroed before use.
  3. Record the hardness value of each tablet and calculate the average hardness for the sample.
  4. If applicable, measure the hardness at multiple points on each tablet to ensure uniformity.

5.3 Adjustment of Compression Parameters

  1. If the measured hardness deviates from the target range (typically ±10% of the target hardness), adjust the compression machine settings as necessary to bring the tablet hardness within specification.
  2. Adjustments may include modifying the compression force, tablet fill weight, or other relevant settings.
  3. After making adjustments, re-sample and re-measure the tablet hardness to verify that the adjustments have resulted in tablets meeting the target hardness.
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5.4 Monitoring Frequency

  1. Tablet hardness should be monitored at regular intervals throughout the compression process, typically every 15 minutes or after processing a set number of tablets (e.g., every 100 tablets).
  2. Additional monitoring should be performed if any irregularities or deviations are observed during production.

5.5 Documentation

  1. Record all hardness measurements, including individual tablet hardness values, the average hardness, and any adjustments made to the compression machine settings, in the batch record (Annexure-2).
  2. Document any deviations from the target hardness and corrective actions taken in the deviation report (Annexure-1).
  3. Ensure all records are signed and dated by the responsible personnel and reviewed by QA for compliance.

5.6 Acceptance Criteria

  1. The tablet hardness should meet the target hardness specified in the product’s formulation guidelines, typically within ±10% of the target hardness.
  2. If the tablet hardness falls outside the acceptable limits, investigate the cause and take corrective actions, which may include reprocessing or rejecting the batch.

5.7 Post-Compression Actions

  1. Once the tablet hardness is within specification, proceed with other post-compression processes, such as coating, packaging, and storage.
  2. Ensure that any adjustments made to the compression machine are recorded and the equipment is cleaned and calibrated as required.

See also  Tablets: SOP for Ensuring Weight Uniformity in Tablets - V 2.0

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 Tablet hardness deviation > 10% Re-adjusted compression force and re-tested John Doe

Annexure-2: Batch Record

Sample Number Tablet Hardness (kg) Average Hardness (kg) Deviation (%) Action Taken
Sample 1 6.5 6.4 ±1.5% 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 hardness acceptance criteria Refined quality control processes QA Head
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