Standard Operating Procedure for Physical Testing of Immediate Release Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/071/2025 |
| Supersedes | SOP/TAB/071/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 05/02/2026 |
| Effective Date | 10/02/2026 |
| Review Date | 05/02/2027 |
1. Purpose
To outline the procedure for conducting physical tests on immediate release tablets, ensuring that they meet the required specifications for physical properties such as weight, hardness, friability, and disintegration.
2. Scope
This SOP applies to the testing of immediate release tablets after compression to verify their physical attributes, including weight, hardness, friability, and disintegration.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing a sample of tablets for physical testing and ensuring the samples are correctly identified.
- Quality Control (QC): Responsible for conducting the physical tests, including weight, hardness, friability, and disintegration, and ensuring that the tablets meet the established specifications.
- Quality Assurance (QA): Ensures compliance with this SOP, reviews the test results, and approves the final product for release.
4. Accountability
The Production Manager is accountable for ensuring that the physical testing procedure is followed during tablet production. The QC Manager is responsible for performing the tests and reporting the results to QA for final approval.
5. Procedure
5.1 Sample Collection
- Collect a sample of tablets from the production batch according to the batch size, as specified in the batch record.
- Ensure that the sample is representative of the entire batch to ensure accurate testing results.
- Label the sample appropriately for identification and ensure it is stored in conditions suitable for testing.
5.2 Weight Testing
- Use a calibrated analytical balance to weigh a sample of tablets from the batch.
- Weigh at least 10 tablets from the batch to determine the average weight.
- Ensure that the average weight of the tablets is within the acceptable limits specified in the batch record.
- Record the individual tablet weights and the average weight in the batch record (Annexure-1).
5.3 Hardness Testing
- Use a tablet hardness tester to measure the hardness of a sample of tablets.
- Test at least 10 tablets and record the hardness of each tablet.
- Ensure that the hardness of the tablets meets the required specifications as outlined in the batch record.
- If any tablets fall outside the acceptable range, investigate the cause and document the findings in the deviation report (Annexure-2).
5.4 Friability Testing
- Use a friabilator to test the friability of a sample of tablets.
- Place 10 tablets in the friabilator and rotate for a specified time or number of revolutions as per the batch record.
- Weigh the tablets before and after the test to calculate the percentage of weight loss.
- Ensure that the percentage of weight loss is within the acceptable limits as specified in the batch record.
- Record the results of the friability test in the batch record (Annexure-3).
5.5 Disintegration Testing
- Use a disintegration tester to determine the disintegration time of a sample of tablets.
- Test at least 6 tablets from the batch and monitor the time it takes for each tablet to disintegrate.
- Ensure that the disintegration time is within the specifications outlined in the batch record.
- Record the results of the disintegration test in the batch record (Annexure-4).
5.6 Documentation and Record-Keeping
- Document all test results, including individual tablet weights, hardness measurements, friability percentages, and disintegration times, in the batch record (Annexure-1).
- Record any deviations from the specifications in the deviation report (Annexure-2), including corrective actions taken.
- Ensure that all records are signed, dated, and retained according to the company’s record retention policy.
5.7 Final Approval
- Once all physical tests are completed and the tablets meet the required specifications, the batch is approved for further processing or packaging by the QA Manager.
- If any tablets fail the tests, they should be removed from the batch, and further investigation should be carried out as per the deviation report.
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)
- Friability Test Results (Annexure-3)
- Disintegration Test Results (Annexure-4)
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 Weight | Hardness | Friability | Disintegration Time |
|---|---|---|---|---|
| Batch 001 | 250 mg | 7 kg | 1.5% | 5 minutes |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 002 | Tablet hardness out of specification | Adjusted compression force | John Doe |
Annexure-3: Friability Test Results
| Batch Number | Tablet Sample | Weight Loss (%) | Pass/Fail |
|---|---|---|---|
| Batch 001 | 10 tablets | 1.2% | Pass |
Annexure-4: Disintegration Test Results
| Batch Number | Tablet Sample | Disintegration Time (minutes) | Pass/Fail |
|---|---|---|---|
| Batch 001 | 6 tablets | 5 minutes | Pass |
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 | Improved Test Method | QA Head |