Standard Operating Procedure for Monitoring Drying Time in Sugar-Coating Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/157/2025 |
| Supersedes | SOP/TAB/157/2022 |
| 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 monitoring and controlling drying time during the sugar-coating process to ensure uniformity in coating thickness and to avoid defects like peeling or uneven coating.
2. Scope
This SOP applies to the sugar-coating process for tablets, specifically to monitoring and controlling the drying time to ensure product quality and consistency during production.
3. Responsibilities
- Coating Operator: Responsible for ensuring the sugar-coating process is conducted properly and for monitoring drying time during the process.
- Quality Control (QC): Responsible for verifying that the drying time parameters are followed and ensuring the tablets meet the quality specifications.
- Quality Assurance (QA): Ensures compliance with the SOP and verifies the correctness of the drying time monitoring process through periodic reviews and audits.
4. Accountability
The Coating Supervisor is accountable for ensuring that the drying time monitoring during the sugar-coating process is accurate and complies with quality specifications. The QA Manager ensures that the process is followed according to this SOP.
5. Procedure
5.1 Preparation for Monitoring Drying Time
- Ensure that the coating pan, airflow, and drying system are calibrated and functioning properly before starting the coating process.
- Verify that the sugar-coating solution is prepared according to the formulation and that the required coating viscosity is achieved.
- Ensure that the batch of tablets is ready for coating and that all required parameters (e.g., tablet weight, size) are within specifications.
5.2 Monitoring the Drying Time
- Start the sugar-coating process and monitor the drying time continuously. Record the time spent on each drying stage in the batch record (Annexure-2).
- Use the automatic or manual system to measure the drying time based on the environmental conditions (e.g., temperature, humidity) and coating thickness.
- Ensure the coating pan rotation speed is optimal to achieve an even coating and facilitate proper drying during each stage.
5.3 Drying Time Adjustments
- If the drying time is too long or too short, adjust the airflow and temperature settings to maintain the ideal drying time, typically between 15-30 minutes, depending on the coating thickness.
- Monitor the temperature and humidity levels in the coating area to ensure they are within the specified range for efficient drying.
- If necessary, adjust the pan speed to ensure proper tablet exposure to the airflow while maintaining an optimal drying time.
5.4 Documentation of Drying Time
- Document the drying time parameters and any adjustments made during the process in the batch record (Annexure-2).
- Note any deviations from the expected drying time, including the causes and corrective actions taken.
- If the drying time exceeds the allowable range, initiate a deviation report (Annexure-1) and take corrective action.
5.5 Quality Control Checks
- Periodically check the tablets during the drying process for any signs of coating defects, such as peeling, uneven coating, or excess moisture.
- Test a sample of the tablets after the drying stage to confirm that the moisture content and coating thickness are within the acceptable limits.
- If any tablets are found to be defective, adjust the drying time, coating solution, or equipment settings to correct the issue.
5.6 Corrective Actions for Drying Time Deviations
- If the drying time is found to be outside the expected range, initiate corrective actions by adjusting airflow, temperature, and pan speed settings.
- Verify that the corrective actions have resolved the issue by re-monitoring the drying time and conducting visual inspections on the next set of tablets.
- Record all corrective actions taken, including the cause of the deviation, adjustments made, and results of re-tests, in the batch record and deviation report.
5.7 Post-Drying Actions
- After the drying process is completed, proceed with the next step in the production process, such as cooling, inspection, and packaging.
- If any defects persist after adjusting the drying process, consult with the QA team for a detailed investigation and review of the procedure.
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)
8. References
- USP <701> – Tablet Coating Specifications
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Manufacturing Guidelines
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 | Drying time exceeded expected range | Adjusted airflow and temperature settings | John Doe |
Annexure-2: Batch Record
| Sample Number | Drying Time | Temperature | Humidity | Action Taken |
|---|---|---|---|---|
| Sample 1 | 25 minutes | 45°C | 55% | 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 drying time monitoring criteria | Improved process control and documentation | QA Head |