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
- Manufacturing Personnel: Responsible for ensuring that the tablets are properly produced and submitted for core hardness testing as part of the quality control process.
- Quality Control (QC): Responsible for performing the core hardness testing on sustained release tablets and recording the results in the batch record. QC ensures that the hardness values meet the required specifications.
- Quality Assurance (QA): Responsible for reviewing the test results and ensuring that the hardness testing procedure is performed according to this SOP. QA also verifies that the tablets meet the release specifications before they are released for further processing.
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
- 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.
- 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.
- Label the tablets for testing with batch number and sample identification to maintain traceability.
- Prepare the testing environment by ensuring that the temperature and humidity levels are within the specified range for testing.
5.2 Core Hardness Testing
- Take a representative sample of tablets (at least 10 tablets per batch) for testing to ensure accurate results.
- Place each tablet on the hardness tester, ensuring that it is aligned correctly to avoid any false readings.
- 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.
- 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.
- 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.
5.3 Post-Test Evaluation
- 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.
- 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.
- 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
- If a tablet batch fails the core hardness test, investigate the potential causes, such as insufficient compression force, inadequate drying, or improper material mixing.
- Take corrective actions based on the findings, such as adjusting the compression force or re-optimizing the formulation.
- Retest the batch after making the necessary adjustments and document the results in the batch record.
- Ensure that the tablets meet the required hardness specifications before proceeding with further processing or release for packaging.
5.5 Documentation and Record-Keeping
- 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).
- Ensure that any deviations from the required hardness specifications are recorded, along with the corrective actions taken, in the deviation report (Annexure-2).
- Store all test results and records for future audits, quality reviews, and regulatory inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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 |