Standard Operating Procedure for Troubleshooting Coating Process Issues in Real-Time
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/155/2025 |
| Supersedes | SOP/TAB/155/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish a standardized procedure for real-time troubleshooting of coating process issues to ensure consistent tablet quality and to address any disruptions in the coating process promptly.
2. Scope
This SOP applies to troubleshooting activities during the coating process of tablets, covering issues such as coating uniformity, defects in coating, spray rate control, and any equipment-related issues.
3. Responsibilities
- Coating Operator: Responsible for identifying and reporting any issues in the coating process, monitoring real-time parameters, and notifying the QC or maintenance team for troubleshooting.
- Quality Control (QC): Responsible for assisting in troubleshooting activities, identifying quality defects, and providing solutions or recommendations to resolve issues during the coating process.
- Maintenance Team: Responsible for supporting troubleshooting efforts related to equipment malfunctions or setup issues in the coating process.
- Quality Assurance (QA): Ensures that all troubleshooting activities are documented, compliant with GMP, and lead to the correction of coating defects to meet product specifications.
4. Accountability
The Coating Supervisor is accountable for ensuring that real-time troubleshooting is executed effectively, ensuring that all equipment and processes are running optimally. The QC Manager and Maintenance Manager are responsible for addressing defects and implementing corrective actions as necessary.
5. Procedure
5.1 Identifying Process Issues
- Monitor coating parameters such as spray rate, airflow, temperature, and tablet bed movement in real time.
- Identify any inconsistencies or deviations in the coating process, such as uneven coating thickness, incomplete coating, excessive or insufficient spray rate, or equipment malfunctions.
- Immediately flag any observations for further investigation, ensuring that the batch remains within specifications and does not compromise product quality.
5.2 Troubleshooting Spray Rate Issues
- If the spray rate is too high or too low, verify the coating solution viscosity and adjust the spray rate control settings accordingly.
- Check for any clogs in the spray nozzles or air spray system that could be affecting the coating distribution.
- Ensure that the correct spray gun settings (e.g., air pressure and fluid pressure) are applied as per the specification.
- If adjustments to the spray rate do not resolve the issue, consult the equipment manual for nozzle or spray system calibration.
5.3 Resolving Coating Defects
- If defects such as peeling, cracking, or uneven coating are observed, stop the coating process and inspect the tablet bed for uniformity in tablet placement and rotation speed.
- Check for any discrepancies in the coating pan speed or temperature that may cause non-uniform coating.
- Verify the coating solution’s composition and viscosity. If the solution is too thick or too thin, adjust it according to the formulation requirements.
- In case of spray gun malfunction, inspect the equipment for blockage, leaks, or misalignment. Clean or replace the nozzles as necessary.
5.4 Monitoring Equipment Performance
- Regularly monitor the functioning of the coating equipment during production, checking for any unusual noises, irregular vibrations, or overheating that might indicate a mechanical failure.
- In case of an equipment malfunction, immediately stop the process and notify the maintenance team to inspect the machine.
- Ensure that all sensors, controllers, and related instruments are calibrated and functioning properly. Calibrate or replace faulty equipment as necessary.
5.5 Documentation of Issues and Actions
- Document all identified issues and troubleshooting actions taken in the batch record (Annexure-2), including the type of issue, root cause (if identified), and corrective action implemented.
- If a significant deviation occurs, generate a deviation report (Annexure-1) and submit it for further investigation and review.
- Record any maintenance actions performed, including equipment servicing or calibration, in the maintenance log.
5.6 Corrective and Preventive Actions
- After resolving the immediate issue, implement corrective actions to prevent recurrence. These actions might include training, equipment upgrades, or procedural changes.
- If necessary, perform a root cause analysis to identify underlying problems that may require long-term solutions or process changes.
- Verify the effectiveness of corrective actions by reviewing subsequent batches and ensuring the process runs without issues.
5.7 Post-Troubleshooting Actions
- After resolving the issues and ensuring the coating process is running smoothly, continue with the production process, ensuring that the batch is inspected for compliance with product specifications.
- If issues persist, escalate the problem to the QA Manager for further review and additional corrective measures.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
- Maintenance Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- USP <701> – Tablet Coating Specifications
- ISO 9001 – Quality Management Systems
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 coating thickness due to improper spray rate | Adjusted spray rate and reworked batch | John Doe |
Annexure-2: Batch Record
| Sample Number | Defect Type | Defect Count | Action Taken |
|---|---|---|---|
| Sample 1 | Uneven coating | 1 | Accepted after correction |
Annexure-3: Maintenance Log
| Maintenance Date | Equipment ID | Issue Description | Corrective Action |
|---|---|---|---|
| 15/12/2025 | Spray Gun-01 | Blockage in nozzle | Cleaned and re-calibrated |
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 troubleshooting steps and actions | Improved coating process stability | QA Head |