QA Manager reviews the inspection results and approves any corrective actions or deviations.

5. Procedure

5.1 Preparation for Inspection

1. Ensure that the inspection area is well-lit and clean to facilitate the accurate identification of defects.
2. Place the coated tablets on an inspection tray or conveyor belt for easy inspection by the operator.
3. 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

1. 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
2. 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).
3. 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

1. Record all observations in the batch record (Annexure-2), noting the type and number of defects found, if any.
2. If defects are found, document the nature and extent of the defects, including whether they are isolated occurrences or affect the entire batch.
3. If defects exceed acceptable limits, generate a deviation report (Annexure-1) and initiate a root cause investigation.

5.4 Corrective Actions

1. If defects are found, take corrective actions such as adjusting the coating process, reformulating the coating solution, or modifying the coating machine settings.
2. Reinspect the tablets after corrective actions have been implemented to ensure the defects have been resolved.
3. Document any corrective actions taken and verify their effectiveness through further inspection or testing.

5.5 Acceptance Criteria

1. 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).
2. 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

1. If the batch passes the inspection, proceed with the next steps in tablet production, such as packaging and labeling.
2. 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

1. Batch Record (Annexure-2)
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