corrective actions or deviations.

5. Procedure

5.1 Preparation for Inspection

1. Ensure the inspection area is well-lit and clean to facilitate accurate inspection of tablet markings.
2. Verify that all inspection tools, such as magnifying glasses or automated tablet marking inspection systems, are properly calibrated and ready for use.
3. Confirm that the compression machine is properly set up to apply the required tablet markings according to the design specifications.

5.2 Marking Inspection Method

1. Inspect each tablet for the following:
   • Legibility of the marking (e.g., text, logo)
   • Consistency of the marking (e.g., uniformity of depth, size, and location)
   • Presence of any defects such as smudging, incomplete markings, or double markings
   • Correct positioning of the marking on the tablet surface
2. Inspect a representative sample from each batch of tablets. The sample size should be defined in the sampling plan (e.g., 100 tablets per batch).
3. If using an automated inspection system, verify that it is functioning correctly and flagging any tablets with defective markings.

5.3 Documentation of Inspection Results

1. Document the results of the marking inspection in the batch record (Annexure-2), noting the type and number of defects found, if any.
2. If defects are found, document the nature 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 an investigation.

5.4 Corrective Actions

1. If defects are found, take corrective actions such as adjusting the compression machine settings or modifying the tablet design or marking process.
2. After corrective actions are taken, perform further inspection to verify that the defects have been resolved.
3. Document any corrective actions taken and verify their effectiveness through further inspections or tests.

5.5 Acceptance Criteria

1. The batch of tablets is considered acceptable if the marking defects do not exceed the predefined threshold (e.g., no more than 2% of the tablets from the sample show defects).
2. Minor defects, such as slight smudging that does not affect tablet identification, may be acceptable within predefined limits.

5.6 Post-Inspection Actions

1. If the batch passes the inspection, proceed with further tablet manufacturing steps, such as drying, coating, or packaging.
2. If the batch fails, perform a root cause analysis, modify the marking process, and re-inspect until the correct marking quality is achieved.

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 Marking Specifications
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Guidelines for Tablet Marking

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	Inconsistent tablet markings during compression	Adjusted compression machine settings and rechecked marking alignment	John Doe

Annexure-2: Batch Record

Sample Number	Marking Defect Type	Defect Count	Action Taken
Sample 1	Smudged marking	1	Accepted
Sample 2	Missing marking	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 marking inspection criteria	Improved defect identification process	QA Head