integrity, disintegration, and release.

Quality Assurance (QA) Team: Reviews and approves the validation plan, process parameters, and results, ensuring that the process complies with GMP and regulatory standards.

Engineering Team: Ensures that the enteric coating equipment is properly calibrated, maintained, and functioning during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the enteric coating process is validated according to this SOP. The QA Manager is responsible for reviewing and approving the validation results and ensuring compliance with GMP and regulatory standards.

5. Procedure

5.1 Preparation for Enteric Coating Validation

Before initiating the validation, ensure the following preparations are made:

1. Review Validation Plan
   1. Review the validation plan, which should include objectives, equipment, materials, process parameters, and acceptance criteria. Ensure that the plan is approved by the QA department before starting the validation activities.
2. Gather Materials and Equipment
   1. Ensure that all necessary materials, including enteric coating solutions, capsule shells, and any excipients, are available and meet the quality specifications for the validation process.
   2. Ensure that the enteric coating equipment, including spray coating systems, curing ovens, and drying equipment, are available and ready for use.
3. Calibrate Equipment
   1. Ensure that all enteric coating equipment is calibrated, including spray nozzles, temperature control systems, and drying systems. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Enteric Coating Process Validation

Follow these steps to validate the enteric coating process:

1. Pre-Validation Setup
   1. Set up the enteric coating system according to the SOP for coating operations. Ensure that the process parameters such as spray rate, coating solution temperature, and drying temperature are properly set.
   2. Ensure that the environmental conditions, such as temperature and humidity, are controlled and documented in the Environmental Monitoring Log (Annexure 2).
2. Start the Coating Process
   1. Start the enteric coating process by feeding the capsules into the coating system and applying the coating solution using the pre-determined spray rate and temperature conditions.
   2. Monitor the process to ensure uniform coating and proper curing, and record all relevant parameters in the Enteric Coating Process Log (Annexure 3).
3. Monitor Process Parameters
   1. Monitor key parameters such as spray rate, solution temperature, drying time, and coating thickness throughout the validation process.
   2. Ensure that the parameters are within the defined limits and that the capsule coating meets the specified uniformity criteria. Record observations and data in the Enteric Coating Validation Log (Annexure 4).
4. Quality Control Testing
   1. After coating, test the capsules for coating integrity, disintegration time, and drug release. Perform additional tests such as dissolution and hardness testing as required.
   2. Document the test results in the Enteric Coating QC Report (Annexure 5) and ensure that the results meet the acceptance criteria.
5. Assess Results and Approve Validation
   1. Review the results from the validation run and assess whether all process parameters and product attributes meet the established criteria. If successful, approve the process for routine production.
   2. If any deviations or non-conformances are identified, investigate the cause and take corrective actions. Revalidate the process if necessary.

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

1. Coating Process Validation Report
   1. Prepare the Enteric Coating Process Validation Report (Annexure 6) summarizing the validation activities, results, and any corrective actions taken.
2. Approval of Validation Results
   1. Review and approve the validation report to ensure that all data meets the validation criteria. The report should be signed and approved by the QA Manager.

5.4 Documentation

Ensure proper documentation of the process for traceability and regulatory compliance:

1. Enteric Coating Process Log
   1. Document all process parameters, including spray rate, solution temperature, drying time, and coating thickness, in the Enteric Coating Process Log (Annexure 3).
2. Enteric Coating QC Report
   1. Document all quality control test results in the Enteric Coating QC Report (Annexure 5).
3. Coating Process Validation Report
   1. Complete the Enteric Coating Process Validation Report (Annexure 6) and ensure it is signed and approved by the QA Manager.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• API: Active Pharmaceutical Ingredient
• RPM: Revolutions Per Minute

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Environmental Monitoring Log
3. Annexure 3: Enteric Coating Process Log
4. Annexure 4: Enteric Coating Validation Log
5. Annexure 5: Enteric Coating QC Report
6. Annexure 6: Coating Process Validation Report

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• Good Manufacturing Practice (GMP) 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: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Coating Machine 202	01/02/2025	John Doe	Spray nozzle and temperature calibration	01/02/2026

Annexure 2: Environmental Monitoring Log

Date	Temperature (°C)	Humidity (%)	Operator	Remarks
02/02/2025	22°C	50%	Jane Smith	No issues

Annexure 3: Enteric Coating Process Log

Batch ID	Process Date	Operator	Spray Rate (L/hr)	Coating Solution Temp (°C)	Drying Temp (°C)	Remarks
Batch 001	02/02/2025	John Doe	5 L/hr	25°C	50°C	Coating uniform

Annexure 4: Enteric Coating Validation Log

Batch ID	Validation Date	Operator	Test Parameters	Results
Batch 001	02/02/2025	Jane Smith	Coating uniformity, disintegration time	Pass

Annexure 5: Enteric Coating QC Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Coating Integrity	Pass	No issues
Batch 001	02/02/2025	Disintegration Time	Pass	Meets specification

Annexure 6: Coating Process Validation Report

Batch ID	Validation Date	Operator	Test Parameters	Results	Action Taken
Batch 001	02/02/2025	John Doe	Coating uniformity, dissolution	Pass	Approved for routine production