Standard Operating Procedure for Visual Inspection of Coated Tablets for Defects
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/150/2025 |
| Supersedes | SOP/TAB/150/2022 |
| 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 a visual inspection of coated tablets for defects to ensure the tablets meet the required quality standards before packaging.
2. Scope
This SOP applies to the visual inspection process for coated tablets during the final stages of tablet production to ensure they are free from defects such as chips, cracks, discoloration, or coating inconsistencies.
3. Responsibilities
- Quality Control (QC): Responsible for performing the visual inspection of coated tablets and documenting any defects observed.
- Production Operator: Responsible for ensuring that the tablets are correctly placed on inspection trays and notifying QC when a batch is ready for inspection.
- Quality Assurance (QA): Ensures that the visual inspection process is compliant with the SOP, reviews inspection results, and approves any necessary corrective actions or deviations.
4. Accountability
The QC Manager is accountable for ensuring that the visual inspection of coated tablets is performed regularly and in compliance with the SOP. The QA Manager reviews the inspection results and approves any corrective actions or deviations.
5. Procedure
5.1 Preparation for Inspection
- Ensure that the inspection area is well-lit and clean to facilitate the accurate identification of defects.
- Place the coated tablets on an inspection tray or conveyor belt for easy inspection by the operator.
- Verify that all inspection equipment, such as magnifying glasses or automated inspection systems, are properly calibrated and ready for use.
5.2 Visual Inspection Method
- Inspect the tablets for the following common defects:
- Chips or cracks in the coating
- Inconsistent or uneven coating thickness
- Discoloration or staining
- Visible foreign particles embedded in the coating
- Non-uniform tablet shapes
- Inspect a representative sample from each batch of tablets. The sample size should be in accordance with the established sampling plan (e.g., 100 tablets per batch).
- For automated visual inspection, ensure that the machine settings are correct, and the tablets are passing through the system as intended. Review any flagged tablets for defects manually.
5.3 Documentation of Inspection Results
- Record all observations in the batch record (Annexure-2), noting the type and number of defects found, if any.
- If defects are found, document the nature and extent of the defects, including whether they are isolated occurrences or affect the entire batch.
- If defects exceed acceptable limits, generate a deviation report (Annexure-1) and initiate a root cause investigation.
5.4 Corrective Actions
- If defects are found, take corrective actions such as adjusting the coating process, reformulating the coating solution, or modifying the coating machine settings.
- Reinspect the tablets after corrective actions have been implemented to ensure the defects have been resolved.
- Document any corrective actions taken and verify their effectiveness through further inspection or testing.
5.5 Acceptance Criteria
- The batch of tablets is considered acceptable if no more than 1% of the tablets have defects that exceed the predetermined threshold (e.g., no more than 5 tablets out of a 100 tablet sample).
- Defects such as minor discoloration or slight coating imperfections that do not affect the functionality or safety of the tablet are considered acceptable within predefined limits.
5.6 Post-Inspection Actions
- If the batch passes the inspection, proceed with the next steps in tablet production, such as packaging and labeling.
- If the batch fails, investigate the root cause of the defects and take necessary corrective actions. If the batch cannot be reworked to meet standards, it should be rejected and documented accordingly.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Tablet Coating Specifications
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Coating and Inspection of 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 | Coating imperfections found during visual inspection | Adjusted coating parameters and reworked the batch | John Doe |
Annexure-2: Batch Record
| Sample Number | Defect Type | Defect Count | Action Taken |
|---|---|---|---|
| Sample 1 | Minor discoloration | 1 | Accepted |
| Sample 2 | Crack in coating | 0 | 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 inspection criteria | Improved defect identification process | QA Head |