Standard Operating Procedure for Hardness Testing of Chewable Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/078/2025 |
| Supersedes | SOP/TAB/078/2022 |
| 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 conducting hardness testing of chewable tablets to ensure that the tablets meet the required mechanical strength and are capable of withstanding physical stress during handling and packaging.
2. Scope
This SOP applies to the hardness testing of chewable tablets, ensuring that they possess the necessary hardness to withstand the conditions of transportation, storage, and use while remaining easy to chew and digest.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing chewable tablet samples for hardness testing and ensuring that the tablets are free from visible defects.
- Quality Control (QC): Responsible for performing the hardness test, recording the results, and ensuring that the tablets meet the specified hardness criteria.
- Quality Assurance (QA): Ensures that the testing procedure is followed correctly and reviews the results for final batch approval and release.
4. Accountability
The QC Manager is accountable for ensuring that the hardness test is conducted in compliance with this SOP and for reporting the results.
The QA Manager is responsible for reviewing the results and approving the batch for release.
5. Procedure
5.1 Sample Collection
- Collect a representative sample of chewable tablets from the batch as specified in the batch record.
- The sample should consist of 10 tablets (or as specified in the batch record or pharmacopeial guidelines).
- Ensure that the tablets are free from any defects such as cracks, chips, or visible contamination.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Hardness Testing Apparatus
- Ensure that the hardness testing apparatus is clean, calibrated, and functioning properly according to the manufacturer’s instructions.
- Set the testing apparatus to the appropriate test settings, ensuring it is ready to measure tablet hardness according to the guidelines.
- Verify that the apparatus has been checked for accuracy and is in good condition before use.
5.3 Performing Hardness Test
- Place each tablet on the hardness tester and apply the required pressure to measure the force needed to break the tablet.
- Record the force in kilograms (kg) or Newtons (N), as required by the testing method.
- Repeat the test for each tablet in the sample (typically 10 tablets per sample).
5.4 Data Recording and Calculation
- Record the hardness values for each tablet in the batch record (Annexure-1).
- Calculate the average hardness value for the sample, as well as the standard deviation to assess uniformity.
- Ensure that the average hardness falls within the specified range, typically 4–8 kg for chewable tablets, but this may vary depending on the product specifications.
5.5 Hardness Acceptance Criteria
- Ensure that the hardness of the tablets falls within the established limits, as defined in the batch record or pharmacopeial guidelines.
- If any tablet fails to meet the hardness criteria, document the findings in the batch record and initiate an investigation to determine the cause of the failure (Annexure-2).
5.6 Documentation and Record-Keeping
- Document all hardness testing results, including the individual tablet hardness values and the average hardness, in the batch record (Annexure-1).
- Record any deviations from the established hardness specifications in the deviation report (Annexure-2), along with the corrective actions taken.
- Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
5.7 Post-Test Cleanup
- Clean the hardness tester and any associated equipment after each test according to the manufacturer’s instructions and the company’s cleaning SOP.
- Ensure that all testing equipment is properly stored and maintained in good working condition.
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
- USP <1217> – Tablet Hardness Test
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Testing for Tablet Hardness
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 Sample | Hardness (kg) | Average Hardness (kg) |
|---|---|---|---|
| Batch 001 | 10 tablets | 5.0 | 5.2 |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 10/12/2025 | Batch 001 | Tablet hardness below specification | Adjusted formulation for hardness | John Doe |
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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 Parameters | Refined hardness testing procedure | QA Head |