Standard Operating Procedure for Tablet Marking Inspection During Compression
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/152/2025 |
| Supersedes | SOP/TAB/152/2022 |
| 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 performing tablet marking inspection during the compression process to ensure that the markings on the tablets meet the required specifications for identification and branding.
2. Scope
This SOP applies to the inspection of tablet markings during the compression stage of tablet manufacturing, ensuring proper and consistent markings on all tablets.
3. Responsibilities
- Quality Control (QC): Responsible for inspecting tablet markings, ensuring that they are clear, legible, and consistent with the specified design.
- Compression Operator: Responsible for ensuring that the compression machine is set up properly to apply markings and notify QC when a batch is ready for inspection.
- Quality Assurance (QA): Ensures that the marking inspection process is followed correctly, reviews inspection results, and approves any corrective actions or deviations.
4. Accountability
The QC Manager is accountable for ensuring that tablet markings are inspected regularly during compression. The QA Manager ensures the marking inspection process is compliant with the SOP and approves any corrective actions or deviations.
5. Procedure
5.1 Preparation for Inspection
- Ensure the inspection area is well-lit and clean to facilitate accurate inspection of tablet markings.
- Verify that all inspection tools, such as magnifying glasses or automated tablet marking inspection systems, are properly calibrated and ready for use.
- 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
- 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
- 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).
- 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
- Document the results of the marking inspection in the batch record (Annexure-2), noting the type and number of defects found, if any.
- If defects are found, document the nature 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 an investigation.
5.4 Corrective Actions
- If defects are found, take corrective actions such as adjusting the compression machine settings or modifying the tablet design or marking process.
- After corrective actions are taken, perform further inspection to verify that the defects have been resolved.
- Document any corrective actions taken and verify their effectiveness through further inspections or tests.
5.5 Acceptance Criteria
- 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).
- Minor defects, such as slight smudging that does not affect tablet identification, may be acceptable within predefined limits.
5.6 Post-Inspection Actions
- If the batch passes the inspection, proceed with further tablet manufacturing steps, such as drying, coating, or packaging.
- 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
- Batch Record (Annexure-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 |