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
- Quality Control (QC): Responsible for performing hardness testing during the compression process, recording results, and ensuring tablets meet hardness specifications.
- Compression Operator: Responsible for adjusting the compression machine settings to maintain tablet hardness within specification limits during the production process.
- Quality Assurance (QA): Reviews the hardness monitoring data to ensure compliance with the required specifications and investigates deviations.
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.
5. Procedure
5.1 Sample Collection
- During the tablet compression process, collect a representative sample of tablets at regular intervals, typically every 15 minutes or according to the batch record.
- The sample size should consist of at least 10 tablets to ensure reliable results.
5.2 Hardness Measurement
- 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).
- Ensure that the tester is properly calibrated and zeroed before use.
- Record the hardness value of each tablet and calculate the average hardness for the sample.
- If applicable, measure the hardness at multiple points on each tablet to ensure uniformity.
5.3 Adjustment of Compression Parameters
- 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.
- Adjustments may include modifying the compression force, tablet fill weight, or other relevant settings.
- After making adjustments, re-sample and re-measure the tablet hardness to verify that the adjustments have resulted in tablets meeting the target hardness.
5.4 Monitoring Frequency
- 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).
- Additional monitoring should be performed if any irregularities or deviations are observed during production.
5.5 Documentation
- 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).
- Document any deviations from the target hardness and corrective actions taken in the deviation report (Annexure-1).
- Ensure all records are signed and dated by the responsible personnel and reviewed by QA for compliance.
5.6 Acceptance Criteria
- The tablet hardness should meet the target hardness specified in the product’s formulation guidelines, typically within ±10% of the target hardness.
- 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
- Once the tablet hardness is within specification, proceed with other post-compression processes, such as coating, packaging, and storage.
- Ensure that any adjustments made to the compression machine are recorded and the equipment is cleaned and calibrated as required.
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-2)
- Deviation Report (Annexure-1)
8. References
- USP <121> – Tablet Hardness Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Specifications 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: 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 |