Standard Operating Procedure for Core Tablet Inspection Before Film Coating
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/143/2025 |
| Supersedes | SOP/TAB/143/2022 |
| 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 inspecting core tablets before the application of the film coating, ensuring that the core tablets meet the required quality specifications for coating application.
2. Scope
This SOP applies to the inspection of core tablets before they are processed in the film coating machine, ensuring that they are free from defects and meet the necessary criteria for successful coating.
3. Responsibilities
- Quality Control (QC): Responsible for performing core tablet inspections and ensuring that the tablets meet the required specifications before coating.
- Tablet Production Operator: Responsible for handling the tablets properly and ensuring they are presented for inspection prior to the coating process.
- Quality Assurance (QA): Ensures compliance with the SOP and reviews inspection data to verify that core tablets are ready for coating.
4. Accountability
The QC Manager is accountable for ensuring that the core tablet inspection process is followed and that any defects are addressed before the coating process. The QA Manager is responsible for reviewing and approving inspection results.
5. Procedure
5.1 Tablet Sampling for Inspection
- From the batch of core tablets, select a representative sample of tablets, typically 10 tablets from different locations within the batch (top, middle, and bottom) to ensure uniformity.
- Ensure that the sample size is sufficient to detect any potential defects or inconsistencies in the batch.
- Weigh the tablets, if necessary, and ensure they meet the required weight specifications before proceeding to the inspection phase.
5.2 Visual Inspection
- Perform a visual inspection of each selected tablet for common defects, such as cracks, chips, surface irregularities, or improper tablet shape.
- Ensure that the tablet’s edges are smooth, and the surface is free from visible marks, stains, or foreign particles.
- Examine the tablet for uniformity in size and shape. If any tablet does not meet the specified dimensions, it should be discarded or marked for reprocessing.
- If any tablets exhibit visible defects, remove them from the batch, and notify the production team to address the root cause of the defect.
5.3 Hardness and Friability Testing (if applicable)
- Perform hardness and friability tests on a sample of tablets to ensure that they are mechanically stable enough for coating. These tests should be performed according to established specifications for the tablet formulation.
- If tablets do not meet the hardness or friability specifications, the batch should be investigated for potential process issues, such as improper compression force or inappropriate excipient selection.
5.4 Surface Moisture Check
- Ensure that the tablets have a proper surface moisture level suitable for the coating process. Excessive moisture may affect the adhesion of the coating material, while too little moisture may result in poor tablet bonding.
- If necessary, perform moisture content testing on the tablets to confirm that they fall within the desired range, as specified for the specific formulation.
5.5 Cleaning and Handling
- Ensure that the core tablets are handled with care during the inspection process to avoid introducing any contamination or damage to the tablet surface.
- If contamination is detected (e.g., dust, particles), gently clean the surface using a soft, lint-free cloth or air blower, ensuring that no additional defects are introduced.
- Only pass clean, intact, and defect-free tablets to the coating stage of the production process.
5.6 Documentation
- Document the results of the core tablet inspection in the batch record (Annexure-2), including details of any defects found, the number of defective tablets removed, and any corrective actions taken.
- If any defects are identified that affect a significant portion of the batch, create a deviation report (Annexure-1), detailing the cause of the issue and the actions taken to resolve it.
- Ensure all inspection data is signed, dated, and reviewed by QA to confirm compliance with the specifications and quality standards.
5.7 Acceptance Criteria
- Core tablets should be free from any cracks, chips, or surface defects that could interfere with the coating process or affect tablet quality.
- The tablets should meet the size and weight specifications, and the moisture content should fall within the acceptable range for the coating process.
- If the core tablets do not meet the specified criteria, they must not be processed in the film coating machine and should either be rejected or sent for reprocessing.
5.8 Post-Inspection Actions
- If the batch passes the inspection, it should be transferred to the coating department for further processing.
- Ensure that the inspection results are recorded and retained in the batch record, as part of the traceability and quality assurance process.
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 Compression and Coating Processes
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Core Tablet Specifications for Coating
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 | Core tablet defects (chips) found during inspection | Removed defective tablets and adjusted compression settings | John Doe |
Annexure-2: Batch Record
| Sample Number | Tablet Size/Shape | Defects Found | Action Taken |
|---|---|---|---|
| Sample 1 | 8 mm round | No defects | 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 tablet inspection process | Improved inspection methods | QA Head |