compressed air, and documenting the results of the validation process.

Quality Assurance (QA) Team: Reviews and approves the validation documentation to ensure compliance with GMP and regulatory standards.

Production Team: Ensures that the compressed air system is integrated into the production process and that it functions properly during capsule production.

4. Accountability

The Engineering Supervisor is responsible for ensuring that the compressed air system is installed and operating correctly. The QA Manager is responsible for reviewing and approving the validation results to ensure compliance with GMP and regulatory standards. The Production Supervisor ensures that the compressed air system remains functional during capsule production.

5. Procedure

5.1 Pre-Validation Setup

Before starting the validation process, ensure the following steps are completed:

1. Review Validation Plan
   1. Review the validation plan to ensure it includes all the necessary tests, system specifications, and acceptance criteria. The plan should be approved by the QA department before proceeding.
2. Prepare the System
   1. Ensure the compressed air system is installed and connected to the required equipment, with no leaks and all necessary filters, regulators, and dryers in place.
   2. Verify that the system is capable of maintaining the required pressure and airflow across all points of use in the production area.
3. Calibrate the Equipment
   1. Calibrate the airflow, pressure, and temperature sensors in the compressed air system according to the manufacturer’s guidelines. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Performance Qualification (PQ) Testing

Follow these steps to perform the performance qualification of the compressed air system:

1. Verify Pressure and Airflow
   1. Measure the pressure and airflow at various points in the system using calibrated instruments. Ensure that the system meets the required specifications for pressure (e.g., 5-7 bar) and airflow rate.
2. Test Air Quality
   1. Perform tests to ensure the air quality is appropriate for capsule production. Test for contaminants such as oil, moisture, and particles. Ensure that the compressed air meets the specified limits for these contaminants.
3. Verify Consistency Over Time
   1. Run the system for a specified period to verify that the pressure, airflow, and air quality remain consistent over time. Document all results in the Validation Log (Annexure 2).
4. Test Alarm Systems
   1. Verify that the alarm system activates when pressure or airflow falls outside of the specified range. Ensure that the system provides adequate warnings to prevent product quality issues.
5. Document PQ Results
   1. Document the results of all performance tests. If any deviations are found, investigate and take corrective actions. Re-test the system until it meets the required specifications.

5.3 Post-Qualification Activities

After successful completion of the PQ process, ensure the following tasks are completed:

1. System Integration into Production
   1. Once the compressed air system passes the PQ tests, integrate the system into regular production operations and ensure it is operational during all capsule production runs.
2. Operator Training
   1. Train operators on how to monitor and maintain the compressed air system during production. Provide training on how to respond to alarms and take corrective actions if required.
3. Sign-Off and Approval
   1. Ensure the validation process is complete, and the compressed air system is signed off by the QA Manager. The PQ Report should be approved and filed for record-keeping.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• PQ: Performance Qualification
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Performance Qualification Log
3. Annexure 3: Performance Qualification Report

8. References

• FDA Guidelines on Compressed Air System Validation
• Good Manufacturing Practice (GMP) Guidelines
• USP <797> – Pharmaceutical Compounding – Sterile Preparations

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
Compressed Air System 102	01/02/2025	John Doe	Calibration of pressure and airflow sensors	01/02/2026

Annexure 2: Performance Qualification Log

Batch ID	PQ Date	Operator	Test Type	Results
Batch 001	02/02/2025	Jane Smith	Pressure and Airflow Test	Pass

Annexure 3: Performance Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	HVAC System Test	Pass	System passed all tests and is ready for production

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for validation of compressed air systems in capsule manufacturing	QA Head
01/02/2025	2.0	Updated validation criteria and added new system checks	Improvement of validation tests and inclusion of updated requirements	QA Head