Standard Operating Procedure for Online Hardness Testing in Tablets During Compression
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/168/2025 |
| Supersedes | SOP/TAB/168/2022 |
| 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 performing online hardness testing on tablets during the compression process, ensuring that the tablets meet the required hardness specifications before moving to the next stage.
2. Scope
This SOP applies to the hardness testing of tablets during the compression process, specifically utilizing online hardness testing systems to ensure the tablet hardness meets predefined specifications for product quality.
3. Responsibilities
- Production Operator: Responsible for performing online hardness testing during the compression process and ensuring that the tablets meet the required hardness specifications.
- Quality Control (QC): Responsible for reviewing online hardness testing results and verifying that the hardness of the tablets is within the acceptable range.
- Quality Assurance (QA): Ensures that the online hardness testing procedure is performed as per this SOP and reviews the results for compliance with GMP standards.
4. Accountability
The Production Supervisor is accountable for ensuring that online hardness testing is conducted properly during compression. The QC Manager is responsible for verifying the test results and ensuring compliance with product specifications.
5. Procedure
5.1 Preparation for Online Hardness Testing
- Ensure that the tablet press is set up according to the batch record, and the compression machine is calibrated properly for the desired tablet hardness range.
- Verify that the online hardness testing equipment is functioning properly and calibrated according to the manufacturer’s instructions.
- Ensure that all necessary documentation, such as the batch record and hardness test specifications, are available and up-to-date.
- Check that all required tools and devices for sample collection and testing are available and in good working condition.
5.2 Performing Online Hardness Testing
- Initiate the compression process as per the batch record. The online hardness tester will automatically collect tablet samples from the compression process at regular intervals.
- Monitor the online hardness testing system to ensure that it is functioning properly and providing continuous data for tablet hardness during the compression process.
- Ensure that the hardness values are recorded automatically by the online system for each sampled tablet and compare them to the predefined acceptable hardness range specified in the batch record.
- In case of any deviations or out-of-range results, the system should automatically alert the operator for review and corrective actions.
5.3 Reviewing Hardness Test Results
- After each batch, review the hardness test results recorded by the online testing system. Ensure that the average hardness values fall within the acceptable range for the product specification.
- In case the results show significant variation or fail to meet the required hardness specifications, perform corrective actions such as adjusting the compression force or re-calibrating the equipment.
- Document all hardness test results in the batch record (Annexure-2), including the time, date, and any adjustments made to the process based on test results.
5.4 Corrective Actions for Hardness Failures
- If the tablets do not meet the required hardness specifications, initiate corrective actions such as:
- Re-adjusting the compression force settings or tablet press speed.
- Verifying and adjusting the formulation if needed.
- Performing re-calibration of the hardness testing system if necessary.
- After implementing the corrective actions, continue the compression process and re-test the tablet hardness until the results meet the specifications.
- Document all corrective actions taken and ensure that they are reviewed by the QA team for compliance before proceeding with the production process.
5.5 Acceptance Criteria
- The batch is considered acceptable if the hardness test results meet the required specifications for tablet hardness, with no significant deviations or out-of-range results.
- If hardness failures occur, the batch may be considered for rework, or the defective tablets may be rejected, depending on the severity of the issue.
- If the corrective actions result in successful re-testing, the batch may proceed to the next stage in the manufacturing process.
5.6 Post-Testing Actions
- If the batch passes the hardness test, document the results in the batch record and proceed with the next stage in the tablet manufacturing process, such as coating or packaging.
- If the batch fails and corrective actions are taken, re-test the tablets and document the updated results in the batch record.
- Ensure that all records are completed and stored according to the company’s document retention policy.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Tablet Hardness Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Hardness Guidelines
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 | Hardness out of range | Adjusted compression force and recalibrated system | John Doe |
Annexure-2: Batch Record
| Time | Hardness Test Result | Tested By |
|---|---|---|
| 08:00 AM | Pass – 8kg | Jane Smith |
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 hardness test procedure | Improved testing method | QA Head |