Standard Operating Procedure for Scaling Up Sugar Coating for Commercial Production
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/068/2025 |
| Supersedes | SOP/TAB/068/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 20/01/2026 |
| Effective Date | 25/01/2026 |
| Review Date | 20/01/2027 |
1. Purpose
To define the procedure for scaling up the sugar coating process from laboratory or pilot scale to commercial production, ensuring consistent quality and coating uniformity.
2. Scope
This SOP applies to the scaling up of sugar coating processes for tablet production from pilot scale to full commercial batch size.
3. Responsibilities
- Manufacturing Personnel: Responsible for implementing the scaled-up sugar coating process and ensuring the batch meets quality standards.
- Quality Control (QC): Responsible for monitoring the coating uniformity, tablet appearance, and any defects during the scaling up process.
- Quality Assurance (QA): Ensures compliance with this SOP and reviews batch records for final approval of the scaled-up process.
- Process Engineers: Responsible for adjusting process parameters based on laboratory or pilot scale results to achieve commercial scale production targets.
4. Accountability
The Production Manager is accountable for overseeing the scaling-up of the sugar coating process and ensuring it meets the required quality standards. The QA Manager is responsible for approving the process and confirming that all validation steps are followed.
5. Procedure
5.1 Pre-Coating Setup
- Review the pilot-scale sugar coating process parameters and batch records to identify key settings, including coating solution concentration, pan speed, spray rate, and drying conditions.
- Ensure that the tablet press and coating pan are cleaned and set up for the larger batch size, with adequate space for the tablets to move and receive uniform coating.
- Prepare the coating solution based on pilot scale results, adjusting the volume to accommodate the larger batch size. Ensure the solution has the proper viscosity and is filtered to remove any particles.
- Ensure all ingredients for the sugar coating are available in sufficient quantities to meet the commercial production batch requirements.
5.2 Scaling Up the Process
- Start by applying the initial layer of sugar coating at the same conditions as the pilot scale, but adjust the spray rate and pan speed to account for the increased batch size.
- Monitor the coating for uniformity and appearance, making adjustments as necessary to maintain the desired coating quality.
- Apply each subsequent layer of sugar coating, ensuring even distribution of the coating solution on the tablets and maintaining consistency with the pilot scale process parameters.
- Ensure that the drying process between layers is consistent with the time and temperature settings used at pilot scale, adjusting air pressure or temperature if necessary to match commercial production requirements.
5.3 Monitoring During Coating
- Monitor the temperature, humidity, and airflow throughout the coating process to ensure consistent drying conditions for each layer.
- Perform visual inspections of the tablets every 30 minutes to ensure the coating is being applied uniformly. Look for defects such as uneven coating, drips, or streaking.
- Sample tablets periodically for coating weight and appearance. Ensure that the coating weight meets the specifications for the batch size.
- Make adjustments to the process parameters (e.g., spray rate, pan speed, air pressure) if any deviations from the desired coating quality are detected.
5.4 Post-Coating Inspection
- Once the final layer of sugar coating has been applied, inspect the tablets for uniformity of coating, appearance, and defects.
- Conduct a coating thickness test on a sample of tablets to ensure the coating meets the required specifications.
- Perform a hardness test to ensure that the tablets maintain structural integrity and that the coating does not cause the tablets to break or crack.
- If any tablets fail the inspection, isolate them for rework or discard them according to the deviation report (Annexure-1).
5.5 Documentation and Record-Keeping
- Document all process parameters, including spray rate, pan speed, drying conditions, coating weight, and inspection results in the batch record (Annexure-2).
- Record any deviations or issues encountered during the process in the deviation report (Annexure-1), along with corrective actions taken.
- Ensure all records are signed, dated, and retained according to the company’s record retention policy for future audits and inspections.
5.6 Calibration and Maintenance of Coating Equipment
- Ensure that the coating equipment is properly calibrated before the scaling-up process begins. Verify that the spray nozzles, air pressure settings, and pan speed are functioning correctly.
- Perform regular maintenance of the coating equipment according to the manufacturer’s specifications to avoid any equipment failure during the scaling-up process.
- Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).
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-2)
- Deviation Report (Annexure-1)
- Equipment Maintenance Log (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: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Uneven coating | Adjusted spray rate | John Doe |
Annexure-2: Batch Record
| Batch Number | Spray Rate | Pan Speed | Air Pressure | Coating Weight |
|---|---|---|---|---|
| Batch 001 | 100 ml/min | 20 rpm | 2 bar | 10 mg |
Annexure-3: Equipment Maintenance Log
| Maintenance Date | Equipment | Maintenance Performed | Performed By | Comments |
|---|---|---|---|---|
| 12/12/2025 | Coating Pan | Inspection and cleaning | Jane Smith | System in good condition |
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 Coating Parameters | Improved Process Efficiency | QA Head |