Standard Operating Procedure for Enteric Coating Film Adhesion Testing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/035/2025 |
| Supersedes | SOP/TAB/035/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 02/08/2025 |
| Effective Date | 07/08/2025 |
| Review Date | 02/08/2026 |
1. Purpose
This SOP describes the procedure for conducting the film adhesion test on enteric-coated tablets. The test ensures that the enteric coating adheres properly to the tablet core, maintaining the integrity and effectiveness of the coating throughout its shelf life and during gastrointestinal transit.
2. Scope
This SOP applies to all enteric-coated tablets produced in the tablet manufacturing department. It covers the testing of the coating’s adhesion properties to ensure that the film remains intact and does not peel off under specific test conditions.
3. Responsibilities
- Manufacturing Personnel: Responsible for preparing the samples of enteric-coated tablets and submitting them for testing.
- Quality Control (QC): Responsible for conducting the film adhesion test, recording the results, and ensuring that the tablets meet the required specifications.
- Quality Assurance (QA): Ensures that the adhesion test is conducted according to this SOP and reviews the test results for compliance with internal quality standards.
4. Accountability
The QC Manager is accountable for overseeing the testing process and ensuring that it is performed in accordance with this SOP. The QA Manager is responsible for reviewing and approving the test results and ensuring that any issues are addressed appropriately.
5. Procedure
5.1 Pre-Test Preparation
- Ensure that the enteric-coated tablets are prepared according to the approved formulation and have completed the coating process.
- Verify that the test equipment, including adhesion testing apparatus (e.g., a peel test device), is clean and calibrated according to the equipment calibration SOP.
- Label the tablets for testing with batch number and sample identification.
- Prepare the necessary testing environment, ensuring it meets the specified temperature and humidity conditions as outlined in the product specification sheet.
5.2 Conducting the Adhesion Test
- Take a representative sample of tablets (at least 5 tablets per batch) to ensure the accuracy of the test results.
- Place the tablets in the adhesion testing apparatus and ensure they are aligned properly according to the test protocol.
- Apply the specified force or pressure to test the adhesion of the coating. Follow the guidelines for the force or pressure to be used, as indicated in the product specifications.
- For the test, the tablet should be subjected to controlled conditions (e.g., a simulated mechanical stress or simulated digestive environment). If necessary, immerse the tablets in a simulated gastric fluid for a specified period before testing the adhesion.
- During the test, observe if any parts of the coating peel, crack, or show signs of failure. Record the time taken for any noticeable peeling or failure to occur.
- Measure the percentage of coating retention on each tablet sample, recording whether the adhesion passes or fails according to the established criteria (e.g., no significant peeling or loss of coating is acceptable).
5.3 Post-Test Evaluation
- After testing, inspect the tablets for any visible defects such as peeling, cracking, or coating separation.
- Document the adhesion test results in the batch record (Annexure-1), including the test conditions, tablet identification, and the results of the adhesion testing for each tablet sample tested.
- If any tablets fail the adhesion test, investigate the cause of the failure and take corrective actions, such as adjusting the coating process or formulation. Document the investigation findings in the deviation report (Annexure-2).
5.4 Corrective Actions for Failures
- If the coating adhesion is found to be insufficient, stop the batch production and investigate potential causes, such as improper coating formulation, insufficient curing time, or equipment malfunction.
- Revise the coating process as needed based on the investigation findings and perform a re-validation of the adhesion test on the re-coated tablets.
- Notify the QA Manager and document all actions taken, including any adjustments made to the coating process or raw material suppliers, in the batch record and corrective action report (Annexure-3).
5.5 Documentation and Record-Keeping
- Ensure that all adhesion testing data, including the number of tablets tested, the adhesion results, and any corrective actions taken, are documented in the batch record (Annexure-1).
- Store all test results in the quality control database for future reference, regulatory audits, and process improvements.
- Ensure that any failures are reported according to the deviation management procedure and that all corrective actions are documented and tracked to closure.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
- Corrective Action Report (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- 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 Record
| Batch Number | Tablet Type | Adhesion Test Result | Corrective Action | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet A | Pass | None | Coating adhered correctly |
| Batch 002 | Tablet B | Fail | Adjusted coating formulation | Coating peeled off during test |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 05/07/2025 | Batch 002 | Coating film failure during adhesion test | Revised coating formulation and re-tested | John Doe |
Annexure-3: Corrective Action Report
| Action Date | Action Number | Corrective Action Taken | Verification Date | Verified By |
|---|---|---|---|---|
| 06/07/2025 | CA-001 | Revised coating formulation to improve adhesion | 07/07/2025 | Jane Smith |
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 Adhesion Testing Process | Improved Testing Procedure | QA Head |