to validate the dust extraction system’s performance. They document all validation results and report deviations if any are found.

Quality Assurance (QA) Team: Reviews and approves the validation documentation to ensure compliance with GMP and regulatory standards before the system is used for production.

Production Team: Ensures that the dust extraction system operates properly during manufacturing runs and maintains the required environmental conditions for capsule production.

4. Accountability

The Engineering Supervisor is responsible for ensuring the installation and proper functioning of the dust extraction system. The QA Manager is responsible for reviewing and approving the validation results, ensuring compliance with regulatory requirements. The Production Supervisor ensures that the dust extraction system is integrated into regular production and operates correctly during manufacturing processes.

5. Procedure

5.1 Pre-Validation Setup

Before starting the validation process for the dust extraction system, ensure the following steps are completed:

1. Review Validation Plan
   1. Review the validation plan to ensure it includes all required tests, system specifications, and acceptance criteria. The plan must be approved by the QA department before initiating validation.
2. System Installation and Setup
   1. Ensure the dust extraction system is installed in the required production areas and that all components (e.g., ducts, filters, fans) are properly connected and functioning.
   2. Ensure that the system is capable of maintaining the required airflow and suction to effectively remove dust from the environment.
3. Calibrate Monitoring Instruments
   1. Calibrate airflow meters, dust concentration monitors, and other monitoring instruments used to measure system performance. 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 dust extraction system:

1. Verify Airflow Rates
   1. Measure the airflow rates at various points in the system using calibrated instruments to ensure that the system can maintain the required suction levels. Check that the airflow rate meets the specified range (e.g., 1000-2000 CFM).
2. Verify Filtration Efficiency
   1. Test the filtration efficiency of the system to ensure that it is effectively removing particulates from the air. Use particle counters or dust samplers to measure the concentration of airborne dust before and after filtration.
3. Test System Integrity
   1. Check for any leaks in the ducts, filters, and joints in the system that could compromise its efficiency. Use smoke tests or air flow visualization methods to detect leaks.
4. Verify Alarm Systems
   1. Test the alarm systems to ensure that they activate when airflow drops below acceptable levels or when the system detects a failure (e.g., filter blockage or fan malfunction).
5. Document PQ Results
   1. Document the results of all performance qualification tests. If any deviations are found, investigate the causes and take corrective actions. Re-test the system until it meets all required specifications. Record the results in the PQ Log (Annexure 2).

5.3 Post-Qualification Activities

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

1. System Integration into Production
   1. Integrate the validated dust extraction system into regular production operations and ensure that it operates properly during all production runs. Perform periodic checks to ensure continued performance.
2. Operator Training
   1. Train operators on how to monitor and maintain the dust extraction system during production. Provide training on how to respond to alarms, take corrective actions, and perform routine system checks.
3. Sign-Off and Approval
   1. Ensure that the PQ process is completed successfully and the system is signed off for use in production. The PQ Report should be reviewed and approved by the QA Manager 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 Dust Extraction Systems for Pharmaceutical Facilities
• 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
Dust Extractor 202	01/02/2025	John Doe	Calibration of airflow meter	01/02/2026

Annexure 2: Performance Qualification Log

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

Annexure 3: Performance Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Dust Extraction System Test	Pass	System passed all airflow and filtration tests

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 dust extraction systems	QA Head
01/02/2025	2.0	Updated validation criteria and added new system checks	Inclusion of updated tests and requirements	QA Head