Standard Operating Procedure for Friability Testing for Sugar-Coated Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/073/2025 |
| Supersedes | SOP/TAB/073/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 15/02/2026 |
| Effective Date | 20/02/2026 |
| Review Date | 15/02/2027 |
1. Purpose
To provide the procedure for conducting friability testing on sugar-coated tablets to ensure that they meet the required mechanical strength and durability criteria.
2. Scope
This SOP applies to the friability testing of sugar-coated tablets to evaluate their ability to withstand mechanical stress during handling and packaging.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing samples of sugar-coated tablets for friability testing.
- Quality Control (QC): Responsible for performing the friability test, recording the results, and ensuring the tablets meet the specified friability limits.
- Quality Assurance (QA): Ensures that the testing is performed according to this SOP and reviews the test results for batch release.
4. Accountability
The QC Manager is accountable for ensuring that the friability test is conducted according to 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 Preparation
- Collect a representative sample of sugar-coated tablets from the batch. A typical sample should consist of 10 tablets, but this may vary depending on the batch size.
- Ensure that the sample is free from any visible defects such as cracks or chips.
- Label the sample appropriately and store it in conditions suitable for testing.
5.2 Friability Test Setup
- Ensure the friabilator is clean, calibrated, and functioning correctly according to the manufacturer’s instructions.
- Set the friabilator to the correct speed (typically 25 rpm) and time (usually 4 minutes), ensuring that the equipment is ready for testing.
- Weigh the initial sample of 10 tablets and record their total weight in the batch record (Annexure-1).
5.3 Conducting the Friability Test
- Place the 10 sugar-coated tablets in the friabilator drum.
- Activate the friabilator and allow the tablets to rotate for 100 revolutions (approximately 4 minutes).
- After the specified time, remove the tablets from the friabilator and weigh them again, recording the final weight in the batch record (Annexure-1).
5.4 Calculate the Friability
- Calculate the percentage of weight loss using the following formula:
- Ensure that the friability of the tablets is within the acceptable limits, typically less than 1% weight loss, but this may vary depending on the product specifications.
- Record the friability result in the batch record (Annexure-1). If the weight loss exceeds the specified limits, document the findings in the deviation report (Annexure-2).
Friability (%) = (Initial weight – Final weight) / Initial weight x 100
5.5 Documentation and Record-Keeping
- Document all results of the friability test, including the initial and final weights of the tablets and the calculated friability percentage, in the batch record (Annexure-1).
- Record any deviations from the established friability limits in the deviation report (Annexure-2), along with corrective actions taken.
- Ensure that all records are signed, dated, and retained according to the company’s record retention policy for future audits and inspections.
5.6 Post-Test Cleanup
- Clean the friabilator after each test according to the manufacturer’s guidelines and the company’s cleaning SOP.
- Ensure that all glassware and equipment used during the friability testing are thoroughly cleaned and stored appropriately.
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 <1216> – Friability Test
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
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 | Initial Weight (g) | Final Weight (g) | Friability (%) |
|---|---|---|---|---|
| Batch 001 | 10 tablets | 10.50 g | 10.45 g | 0.48% |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 001 | Friability > 1% | Reformulated coating composition | 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 Testing Parameters | Improved Testing Method | QA Head |