the required moisture content and other specifications. The team also performs testing on the capsules after drying to ensure they are fit for packaging.

Quality Assurance (QA) Team: Reviews and approves the validation plan and results, ensuring that the drying process meets all GMP and regulatory standards.

Engineering Team: Ensures that the drying equipment is calibrated, maintained, and functioning properly throughout the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the capsule drying process is validated according to this SOP. The QA Manager is responsible for reviewing and approving the validation results and ensuring that the process is compliant with GMP and regulatory standards.

5. Procedure

5.1 Preparation for Capsule Drying Validation

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

1. Review Validation Plan
   1. Review the capsule drying validation plan, which should include the objectives, materials, equipment, personnel, and the criteria for validation acceptance.
   2. Ensure that the validation plan is approved by the QA department before proceeding with the drying process validation.
2. Gather Materials and Equipment
   1. Ensure that the capsules to be dried are available and have passed the required testing before the drying process starts.
   2. Ensure that all equipment, including drying ovens, drying trays, temperature controllers, and moisture analyzers, are available and ready for use.
3. Verify Equipment Calibration
   1. Verify that all drying equipment is properly calibrated, including temperature and humidity monitoring devices. Record this information in the Equipment Calibration Log (Annexure-1).

5.2 Drying Process Validation

Follow these steps to validate the capsule drying process:

1. Pre-Validation Setup
   1. Set up the drying equipment according to the standard operating procedures and ensure that all settings, such as temperature and humidity, are set to the desired values.
   2. Ensure that all necessary parameters for drying, such as time and temperature limits, are recorded in the drying log for monitoring.
2. Drying Procedure
   1. Place the capsules into the drying equipment and initiate the drying process according to the specified conditions, ensuring that the capsules are evenly spaced and not overcrowded.
   2. Monitor key parameters, including temperature, humidity, and drying time, throughout the drying process to ensure they remain within the specified range.
   3. Ensure that the capsules are not exposed to excessive heat or humidity, as this may affect their quality.
3. Monitoring and Adjustments
   1. Monitor the drying process continuously, recording temperatures, humidity, and time at regular intervals in the Drying Log (Annexure-2).
   2. If any of the monitored parameters fall outside the acceptable range, take corrective actions immediately, such as adjusting the equipment settings or removing the capsules from the drying unit.
4. Moisture Content Testing
   1. Test the moisture content of the capsules after the drying process is completed. Use an approved method, such as a moisture analyzer or desiccator, to determine if the capsules meet the required moisture content specifications.
   2. Record the moisture content results in the Capsule Moisture Content Report (Annexure-3) and compare them against the predefined specifications.
5. Assess Results
   1. Review the test results and ensure that the capsules meet the desired moisture content and other quality specifications.
   2. If the results are satisfactory, approve the batch for the next phase of production. If any issues are found, initiate corrective actions and revalidate the drying process if necessary.

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

1. Validation Report
   1. Prepare the Capsule Drying Validation Report (Annexure-4) that includes a summary of the validation activities, test results, and corrective actions (if any) taken during the process.
2. Approval of Validation Results
   1. Review the validation report and ensure all data is consistent with the validation criteria. The report should be approved by the QA Manager before proceeding with routine production runs.

5.4 Documentation

Ensure proper documentation of the drying process validation for traceability:

1. Drying Log
   1. Document the drying conditions for each batch, including time, temperature, humidity, and any corrective actions taken during the validation process.
2. Moisture Content Report
   1. Document the moisture content results of the capsules in the Capsule Moisture Content Report (Annexure-3).
3. Process Validation Report
   1. Complete the process validation report and ensure it is signed by the QA team to verify that the drying process was validated and approved for routine use.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• Moisture Content: The amount of moisture remaining in the capsule shell
• RPM: Revolutions Per Minute

7. Documents

1. Drying Log (Annexure-2)
2. Moisture Content Report (Annexure-3)
3. Process Validation Report (Annexure-4)
4. Equipment Calibration Log (Annexure-1)

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-2: Drying Log

Batch ID	Drying Date	Operator	Time	Temperature	Humidity	Corrections
Batch 001	02/02/2025	John Doe	60 mins	50°C	45%	No corrections

Annexure-3: Moisture Content Report

Batch ID	Moisture Content (%)	Test Date	Operator	Results
Batch 001	8.5%	02/02/2025	Jane Smith	Pass

Annexure-4: Process Validation Report

Batch ID	Validation Date	Operator	Test Parameters	Results
Batch 001	02/02/2025	Jane Smith	Drying Time, Temperature, Humidity	Pass

Annexure-1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Drying Oven 001	02/02/2025	Jane Smith	Temperature calibration	02/02/2026

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 process validation procedure	Improved process controls	QA Head