Standard Operating Procedure for In-Process Friability Testing for Tablets
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/133/2025 |
| Supersedes | SOP/TAB/133/2022 |
| 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 in-process friability testing on tablets during the manufacturing process to ensure they meet the required mechanical strength and resistance to breakage or abrasion.
2. Scope
This SOP applies to the friability testing of tablets during manufacturing. It ensures that tablets maintain their integrity under handling and transportation conditions by evaluating their resistance to breakage.
3. Responsibilities
- Quality Control (QC): Responsible for performing friability tests on tablets, ensuring they meet the required specifications, and documenting the results.
- Production Operator: Responsible for providing tablets for friability testing at designated intervals during the manufacturing process.
- Quality Assurance (QA): Ensures that friability testing is conducted according to this SOP and reviews the results for compliance with quality standards.
4. Accountability
The QC Manager is accountable for ensuring that friability testing is performed accurately and according to this SOP. The QA Manager is responsible for reviewing and ensuring compliance with the test results and quality standards.
5. Procedure
5.1 Sample Collection
- At regular intervals during the tablet manufacturing process, collect a representative sample of tablets from the batch. A minimum of 10 tablets should be sampled for each test.
- Ensure that the sample represents the entire batch by collecting tablets from different locations (top, middle, and bottom of the batch).
5.2 Preparation for Friability Testing
- Before testing, ensure that the tablets are free from visible defects, such as cracks or chips. Any defective tablets should be excluded from the sample.
- Weigh the sample tablets and record the initial weight.
- Place the tablets in a friability testing apparatus, such as a rotating drum, designed to simulate the mechanical forces tablets will be exposed to during handling and transport.
5.3 Friability Testing Method
- Start the friability testing apparatus. The tablets should rotate in the drum for a set number of revolutions, typically 100 turns or for 4 minutes at a specified speed (e.g., 25 rpm).
- After the specified time, remove the tablets from the apparatus and visually inspect them for any significant breakage or loss of mass.
- Weigh the tablets again after testing and record the final weight.
5.4 Calculation of Friability
- Calculate the percentage of weight loss using the following formula:
Friability (%) = (Initial Weight – Final Weight) / Initial Weight × 100
- If the weight loss exceeds the specified limit (usually 1% for most tablets), the batch does not meet the friability criteria and must be rejected or reworked.
5.5 Monitoring and Adjustments
- If the friability of the tablets exceeds the acceptable limit, investigate the possible causes, such as improper compression settings, insufficient binder, or inappropriate tablet formulation.
- Adjust the compression force, binder concentration, or other formulation parameters as necessary to improve tablet hardness and reduce friability.
- Re-sample and re-test the tablets after making adjustments to confirm that the friability is within the acceptable range.
5.6 Documentation
- Record all results from the friability tests, including the initial and final weights of the tablets, the percentage of weight loss, and any corrective actions taken in the batch record (Annexure-2).
- Document any deviations from the acceptable friability limit and the corresponding corrective actions in the deviation report (Annexure-1).
- Ensure that all records are signed, dated, and reviewed by QA to ensure compliance with quality standards.
5.7 Acceptance Criteria
- The friability of tablets should not exceed 1% (unless otherwise specified for a particular formulation or product).
- If the friability exceeds the specified limit, the batch may need to be rejected or reworked.
5.8 Post-Testing Actions
- Once the tablets pass the friability test, proceed with the next stages of tablet manufacturing, such as coating, packaging, and storage.
- Ensure that the friability testing equipment is cleaned and calibrated regularly according to the maintenance schedule.
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 <1216> – Friability and Breakage of Tablets
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Friability Testing for Tablets
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 | Friability exceeded 1% | Adjusted compression settings and binder concentration | John Doe |
Annexure-2: Batch Record
| Sample Number | Friability Test Result | Action Taken |
|---|---|---|
| Sample 1 | Pass (Weight loss: 0.5%) | 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 friability testing procedure | Improved testing standards | QA Head |