SOP Guide for Pharma

Tablets: SOP for Core Hardness Testing for Sustained Release Tablets – V 2.0

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Tablets: SOP for Core Hardness Testing for Sustained Release Tablets – V 2.0

Standard Operating Procedure for Core Hardness Testing for Sustained Release Tablets

Department Tablet
SOP No. SOP/TAB/036/2025
Supersedes SOP/TAB/036/2022
Page No. Page 1 of 6
Issue Date 07/08/2025
Effective Date 12/08/2025
Review Date 07/08/2026

1. Purpose

This SOP outlines the procedure for testing the core hardness of sustained release tablets to ensure that they meet the necessary specifications for mechanical strength and integrity. Core hardness is an important quality attribute that affects tablet durability, release profile, and patient compliance.

2. Scope

This SOP applies to all sustained release tablets produced in the tablet manufacturing department. It covers the testing of tablet core hardness to ensure that the tablets meet the required hardness specifications for optimal performance during handling, storage, and release.

3. Responsibilities

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4. Accountability

The QC Manager is accountable for overseeing the core hardness testing process and ensuring that the tablets meet the required hardness specifications. The QA Manager is responsible for reviewing and approving the test results and ensuring compliance with internal quality standards.

5. Procedure

5.1 Pre-Test Preparation

  1. Ensure that the tablets have been produced and are ready for testing. The tablets should be allowed to cool to room temperature before testing to avoid any moisture influence on the hardness measurement.
  2. Verify that the hardness testing apparatus is calibrated according to the equipment calibration SOP. Ensure that all testing devices are clean and free of any residual material.
  3. Label the tablets for testing with batch number and sample identification to maintain traceability.
  4. Prepare the testing environment by ensuring that the temperature and humidity levels are within the specified range for testing.

5.2 Core Hardness Testing

  1. Take a representative sample of tablets (at least 10 tablets per batch) for testing to ensure accurate results.
  2. Place each tablet on the hardness tester, ensuring that it is aligned correctly to avoid any false readings.
  3. Perform the core hardness test by applying a controlled force to the tablet and measuring the maximum force it can withstand before breaking or deforming.
  4. Record the hardness value for each tablet tested. The hardness value should be measured in kiloponds (kp) or Newtons (N) depending on the test equipment.
  5. Test the core hardness of at least 10 tablets from each batch. If any tablets fail to meet the required hardness specifications, investigate the cause and adjust the manufacturing process accordingly.
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5.3 Post-Test Evaluation

  1. After testing, visually inspect each tablet to check for any signs of cracking, chipping, or excessive wear that could indicate problems with the tablet’s core integrity.
  2. Record the results of the core hardness test in the batch record (Annexure-1), including the average hardness value, range of hardness values, and any deviations observed.
  3. If any tablets fail the core hardness test, document the failure and investigate potential causes, such as formulation issues, manufacturing process problems, or equipment malfunctions. Report the findings in a deviation report (Annexure-2).

5.4 Corrective Actions for Failed Tablets

  1. If a tablet batch fails the core hardness test, investigate the potential causes, such as insufficient compression force, inadequate drying, or improper material mixing.
  2. Take corrective actions based on the findings, such as adjusting the compression force or re-optimizing the formulation.
  3. Retest the batch after making the necessary adjustments and document the results in the batch record.
  4. Ensure that the tablets meet the required hardness specifications before proceeding with further processing or release for packaging.

5.5 Documentation and Record-Keeping

  1. Document all core hardness testing data, including the hardness values for each tablet, test conditions, and any corrective actions taken in the batch record (Annexure-1).
  2. Ensure that any deviations from the required hardness specifications are recorded, along with the corrective actions taken, in the deviation report (Annexure-2).
  3. Store all test results and records for future audits, quality reviews, and regulatory inspections.
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6. Abbreviations

7. Documents

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

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 Record

Batch Number Tablet Type Core Hardness Remarks
Batch 001 Tablet A 6.5 kp Pass
Batch 002 Tablet B 5.8 kp Pass

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
08/07/2025 Batch 002 Core hardness below target range Adjusted compression force and re-tested 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 Test Methodology Improved Hardness Measurement Process QA Head
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