Standard Operating Procedure for Testing Tablet Edges for Chipping in Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/156/2025 |
| Supersedes | SOP/TAB/156/2022 |
| 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 testing tablet edges for chipping during the compression process to ensure that tablets meet the required specifications and are free from damage.
2. Scope
This SOP applies to testing tablet edges for chipping during the compression process, ensuring that the edges are intact and meet the quality standards set for tablet manufacturing.
3. Responsibilities
- Quality Control (QC): Responsible for performing the chipping test on tablets and documenting the results. QC is also responsible for taking corrective actions if excessive chipping is observed.
- Compression Operator: Responsible for ensuring the tablet compression machine is set correctly to minimize edge chipping and notifying QC when tablets are ready for inspection.
- Quality Assurance (QA): Ensures that the chipping test procedure is followed according to the SOP and reviews the documentation for compliance.
4. Accountability
The QC Manager is accountable for ensuring the chipping test is performed regularly and that any chipping-related defects are properly addressed. The QA Manager is responsible for ensuring compliance with this SOP and for approving corrective actions as necessary.
5. Procedure
5.1 Preparation for Testing
- Ensure the inspection area is clean, well-lit, and equipped with magnification tools, such as a magnifying glass or tablet inspection machine, for accurate evaluation of tablet edges.
- Verify that the tablet compression machine is set to the appropriate settings for tablet hardness and shape. This includes checking the die and punch alignment to prevent excessive pressure on tablet edges.
- Collect a sample of tablets for inspection. The sample should be representative of the batch, typically 100 tablets or as per the sampling plan.
5.2 Testing Tablet Edges for Chipping
- Visually inspect each tablet in the sample for chipping or cracks on the edges. Pay particular attention to the corners and perimeter of the tablet.
- If using a magnifying tool, inspect the tablet edges for fine cracks, chips, or missing pieces of coating that may affect tablet integrity or appearance.
- For automated systems, ensure that the tablet inspection machine is calibrated to detect edge defects, and review flagged tablets for manual verification.
5.3 Documentation of Results
- Document the results of the edge inspection in the batch record (Annexure-2), including the number of defective tablets found, the type of defects observed, and the severity of the defects.
- If a tablet has chipped edges, record whether the chipping is minor (cosmetic) or severe (functional impairment). For cosmetic defects, the batch may still be acceptable depending on the tolerance limits set.
- If the number of chipped tablets exceeds the acceptance criteria (e.g., more than 2% of the sample), initiate a deviation report (Annexure-1) and investigate the root cause.
5.4 Corrective Actions
- If excessive chipping is found, investigate the cause. Potential causes may include improper compression settings, worn-out tooling, or inappropriate tablet formulations.
- Adjust the tablet compression machine settings, such as the pressure or tablet hardness, to reduce the likelihood of edge chipping in future batches.
- Ensure that any corrective actions are documented in the deviation report and the batch record. Verify the effectiveness of the corrective actions by re-inspecting the tablets after changes are made.
5.5 Acceptance Criteria
- The batch is considered acceptable if no more than 2% of the tablets in the sample show chipped edges that affect the tablet’s functional integrity.
- Minor chipping that does not affect the tablet’s efficacy or appearance may be acceptable within predefined limits. However, significant chipping or damage to more than 2% of the tablets will require corrective actions.
5.6 Post-Testing Actions
- If the batch passes the edge inspection, proceed with the next step in the production process, such as coating or packaging.
- If the batch fails, perform a root cause analysis to determine the source of the problem and rework the batch or initiate a deviation report for further investigation.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Tablet Marking and Quality Specifications
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Manufacturing 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 | Excessive chipping observed on tablet edges | Adjusted compression pressure and recalibrated machine | John Doe |
Annexure-2: Batch Record
| Sample Number | Defect Type | Defect Count | Action Taken |
|---|---|---|---|
| Sample 1 | Chipped edges | 1 | Accepted after adjustment |
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 chipping inspection criteria | Improved accuracy of edge inspections | QA Head |