Standard Operating Procedure for Final Inspection of Coated Tablets Before Packing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/203/2025 |
| Supersedes | SOP/TAB/203/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP outlines the procedure for conducting the final inspection of coated tablets before they are packed. It ensures that the coated tablets meet the required quality standards and are free from defects, contamination, or any other issues that could affect their quality or safety.
2. Scope
This SOP applies to all coated tablets produced in the tablet manufacturing department. It covers the inspection process from the completion of the coating process until the tablets are ready for packaging.
3. Responsibilities
- Quality Control (QC): Responsible for conducting the final inspection of the coated tablets, ensuring they meet all predefined specifications, and documenting the results of the inspection.
- Production Team: Responsible for ensuring that the coated tablets are properly prepared and transferred to the inspection area in a timely manner.
- QA Manager: Responsible for overseeing the final inspection process and ensuring compliance with regulatory guidelines and internal quality standards.
- Packaging Team: Responsible for receiving the inspected tablets and ensuring that they are packed in accordance with packaging specifications.
4. Accountability
The QC Manager is accountable for ensuring that the final inspection is conducted according to this SOP. The Production Manager is responsible for ensuring the timely transfer of the coated tablets to the QC inspection area.
5. Procedure
5.1 Preparation for Final Inspection
- Ensure that the coated tablets are transferred from the coating machine to the inspection area in a clean and organized manner, free from any contamination.
- Verify that the correct batch of coated tablets is available for inspection, and ensure that the batch records and production logs are up to date (Annexure-1).
- Ensure that all necessary inspection tools and equipment (e.g., magnifying glass, calipers, sampling containers) are available and in good condition for the inspection process.
5.2 Inspection of Coated Tablets
- Visually inspect a representative sample of coated tablets for any visible defects such as chips, cracks, discoloration, or any coating irregularities.
- Check the uniformity of the coating, ensuring that the tablets have an even coat without peeling or flaking. Look for any signs of over-coating or under-coating (Annexure-2).
- Ensure that the color of the tablets matches the specified color requirements and that no foreign particles are present on the tablets.
- Measure the thickness of the coating on the tablets using calipers or other appropriate measuring tools. Ensure that the coating thickness falls within the acceptable range specified in the batch records (Annexure-3).
- Perform a hardness test on a representative sample of the tablets to ensure that they are within the specified hardness range, as this can be affected by the coating process.
- Conduct a friability test on a representative sample to ensure that the tablets do not break or chip during normal handling.
5.3 Documentation of Inspection Results
- Record all inspection results, including visual inspection, coating thickness, hardness, and friability test results, in the Final Inspection Log (Annexure-4).
- If any defects or deviations from the specifications are identified during the inspection, document them immediately in the deviation log and notify the QA team for further investigation.
- Ensure that all inspection records are signed by the responsible QC personnel and that the batch number, inspection date, and time are clearly recorded.
5.4 Acceptance or Rejection of Coated Tablets
- If the coated tablets pass the inspection criteria, approve them for packaging by updating the batch records and marking the batch as ready for packaging (Annexure-5).
- If any tablets fail the inspection, segregate the rejected tablets, and investigate the cause of the defects. Ensure that corrective actions are documented, and initiate a CAPA process if necessary (Annexure-6).
- Rejected tablets must be properly disposed of or sent for reprocessing in accordance with the company’s waste disposal and rework procedures.
5.5 Final Approval for Packing
- Once the batch passes the final inspection, sign off the inspection report and prepare the tablets for the packaging process.
- Ensure that the packaging team receives the inspected batch along with the appropriate inspection and batch documentation.
- Monitor the transition of the batch from inspection to packaging to ensure that all documentation is complete and accurate.
5.6 Cleaning and Maintenance of Inspection Equipment
- After completing the final inspection, clean all inspection equipment, including magnifying glasses, calipers, and measuring tools, to ensure they remain free from contamination.
- Check that all equipment is properly stored and maintained for future use.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CAPA: Corrective and Preventive Action
- IPQC: In-Process Quality Control
7. Documents
- Batch Records (Annexure-1)
- Coating Inspection Log (Annexure-2)
- Coating Thickness Measurement Log (Annexure-3)
- Final Inspection Log (Annexure-4)
- Inspection Approval and Rejection Report (Annexure-5)
- CAPA Documentation (Annexure-6)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- 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 Records
| Batch Number | Coating Process | Inspection Date | Inspector Name |
|---|---|---|---|
| Batch-12345 | Coating Process-01 | 01/03/2026 | John Doe |
Annexure-2: Coating Inspection Log
| Sample ID | Inspection Type | Result | Remarks |
|---|---|---|---|
| Sample-123 | Visual Inspection | Pass | No defects |
Annexure-3: Coating Thickness Measurement Log
| Sample ID | Measured Thickness | Target Thickness | Deviation |
|---|---|---|---|
| Sample-123 | 0.12mm | 0.12mm | None |
Annexure-4: Final Inspection Log
| Batch Number | Inspection Result | Inspector Name | Approval Status |
|---|---|---|---|
| Batch-12345 | Pass | Jane Smith | Approved |
Annexure-5: Inspection Approval and Rejection Report
| Batch Number | Inspection Status | Action Taken | Comments |
|---|---|---|---|
| Batch-12345 | Approved | Move to packing | No defects found |
Annexure-6: CAPA Documentation
| CAPA ID | Action Description | Completion Date | Responsible Person |
|---|---|---|---|
| CAPA-001 | Investigated and resolved coating issues | 01/04/2026 | John Doe |
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 procedures | Improved defect detection process | QA Head |