for approving the process and confirming that all validation steps are followed.

5. Procedure

5.1 Pre-Coating Setup

1. 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.
2. 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.
3. 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.
4. 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

1. 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.
2. Monitor the coating for uniformity and appearance, making adjustments as necessary to maintain the desired coating quality.
3. 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.
4. 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

1. Monitor the temperature, humidity, and airflow throughout the coating process to ensure consistent drying conditions for each layer.
2. 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.
3. Sample tablets periodically for coating weight and appearance. Ensure that the coating weight meets the specifications for the batch size.
4. 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

1. Once the final layer of sugar coating has been applied, inspect the tablets for uniformity of coating, appearance, and defects.
2. Conduct a coating thickness test on a sample of tablets to ensure the coating meets the required specifications.
3. 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.
4. 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

1. Document all process parameters, including spray rate, pan speed, drying conditions, coating weight, and inspection results in the batch record (Annexure-2).
2. Record any deviations or issues encountered during the process in the deviation report (Annexure-1), along with corrective actions taken.
3. 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

1. 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.
2. Perform regular maintenance of the coating equipment according to the manufacturer’s specifications to avoid any equipment failure during the scaling-up process.
3. 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

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)
3. 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