QA Manager ensures compliance with this SOP and verifies the effectiveness of the process.

5. Procedure

5.1 Coating Material Preparation

1. Prepare the film coating solution according to the formulation guidelines, ensuring the correct type and concentration of polymer, solvent, and any additives.
2. Verify the batch number, Certificate of Analysis (CoA), and expiration date of the coating material before use.
3. Filter the coating solution to remove any contaminants before transferring it to the coating machine’s reservoir.

5.2 Coating Machine Setup

1. Ensure that the coating machine is clean, calibrated, and free from residues of previous batches.
2. Check that the tablet drum is correctly positioned and aligned in the coating machine, ensuring that tablets will tumble evenly during the process.
3. Set up the spray nozzles according to the machine’s specifications, ensuring uniform distribution of the coating material across the tablets.
4. Verify that the airflow, temperature, and spray rate settings are within the specified limits for the coating process.

5.3 Loading Tablets into the Coating Drum

1. Ensure that tablets are free from defects such as cracks or chips before loading them into the coating drum.
2. Load tablets into the drum evenly, making sure that they are not overcrowded to allow for optimal coating coverage.
3. Ensure that the drum is rotating correctly to achieve even distribution of the tablets during the coating process.

5.4 Coating Process

1. Start the coating machine, ensuring the spray system is activated and the tablet drum is rotating smoothly.
2. Gradually introduce the film coating solution into the spray system while adjusting the spray rate, ensuring an even coating distribution across the tablets.
3. Monitor the tablets closely during the coating process for uniformity in coating appearance and thickness.
4. Ensure that the temperature and airflow settings remain stable throughout the process to achieve optimal coating conditions.
5. Continue the process until the required coating thickness is achieved. Avoid over-coating, which could affect tablet hardness or disintegration.

5.5 In-Process Quality Control

1. Perform periodic checks on the tablets during the coating process, including visual inspections for uniformity and checking the coating thickness using a non-destructive measurement tool.
2. Test for coating defects, such as incomplete coverage or streaking, and adjust the spray rate or coating solution if necessary.
3. Record the results of all in-process checks in the batch record (Annexure-1).

5.6 Drying Process

1. After the coating material is applied, ensure that the tablets are dried according to the specified drying time and temperature settings to remove any residual solvent.
2. Monitor the moisture content of the tablets during the drying process using appropriate testing methods, such as loss on drying (LOD).
3. Ensure that tablets are fully dried to prevent any tackiness or adhesion between tablets.

5.7 Post-Coating Inspection

1. After the coating process is completed and the tablets are dried, perform a final inspection for uniformity, appearance, and coating integrity.
2. Check the tablets for defects such as chipping, cracking, or peeling of the coating.
3. Record any issues observed during the inspection in the batch record, and take corrective action if necessary.

5.8 Equipment Shutdown and Cleaning

1. After completing the coating process, shut down the machine and clean all parts that have come into contact with the coating material, such as spray nozzles, tablet drum, and collection containers.
2. Ensure that the machine is thoroughly cleaned to prevent cross-contamination between batches. Record cleaning details in the cleaning log (Annexure-2).

5.9 Documentation and Record-Keeping

1. Document all aspects of the coating process, including setup, parameters, in-process checks, and final inspections in the batch record.
2. Ensure that all records are signed off by the responsible personnel and are stored for regulatory compliance.
3. Ensure that deviations, if any, are documented with corrective actions and reviewed by QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Coating Batch Record (Annexure-1)
2. Cleaning Log (Annexure-2)

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: Coating Batch Record

Batch Number	Tablet Type	Coating Solution	Spray Rate	Tablet Weight	Coating Thickness	Remarks
Batch 001	Tablet A	Film Coating	5 g/min	500 mg	20 µm	Within specifications
Batch 002	Tablet B	Film Coating	7 g/min	510 mg	25 µm	Minor deviation, resolved

Annexure-2: Cleaning Log

Equipment	Cleaning Date	Cleaning Method	Personnel
Coating Machine 1	30/03/2025	Washing with detergent and rinsing with water	John Doe
Coating Machine 2	31/03/2025	Washing with detergent and rinsing with water	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 Coating Process Parameters	Standardization of Film Coating	QA Head