the laminar air flow unit is operated according to the qualification protocols, and that critical parameters are monitored and recorded during testing.
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the laminar air flow unit are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the laminar air flow unit operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the laminar air flow unit meets all performance criteria.
Maintenance Personnel: Ensures that the laminar air flow unit is properly installed, calibrated, and maintained, and that all mechanical and electrical systems are functioning correctly during the qualification process.

4) Procedure

The following steps should be followed for the IQ, OQ, and PQ of laminar air flow units:

1. Installation Qualification (IQ):
1.1 Review the laminar air flow unit specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., electrical power, air supply, filters) are available and meet the specifications required for operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including air filters, fans, blowers, and ducts.
1.5 Ensure that all electrical components, including controllers, alarms, sensors, and data loggers, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.

2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as airflow velocity, filter integrity, and air quality, are properly set and calibrated.
2.2 Conduct a dry run of the laminar air flow unit to verify that it operates without issues. Monitor key parameters such as airflow distribution, velocity, and pressure.
2.3 Test all control systems, ensuring that the start/stop, airflow regulation, and safety systems work correctly.
2.4 Inspect the laminar air flow unit to ensure that it provides the required unidirectional airflow and that the airflow pattern is uniform throughout the unit.
2.5 Verify that the system can maintain the specified airflow velocity and that no contaminants are introduced into the sterile environment.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.

3. Performance Qualification (PQ):
3.1 Conduct the operation of the laminar air flow unit under typical production conditions to monitor performance during routine use.
3.2 Verify that the laminar air flow unit consistently provides the required airflow velocity, cleanliness, and sterility.
3.3 Perform microbial testing to verify that the laminar air flow system effectively maintains a sterile environment by ensuring no microbial contamination in the airflow.
3.4 Measure the airflow velocity at various points in the laminar air flow unit to confirm that it falls within the specified range.
3.5 Ensure that the system performs at the required throughput and meets regulatory guidelines for air cleanliness and contamination control.
3.6 Document the results of the PQ, including microbial test results, airflow velocity, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.

4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for airflow, temperature, and pressure.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the laminar air flow unit. This analysis should confirm that the unit operates consistently within predefined parameters and meets the acceptance criteria for air cleanliness and sterility.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the laminar air flow unit’s performance.

5. Requalification:
5.1 Requalify the laminar air flow unit if significant changes are made to the equipment, such as replacing major components, relocating the unit, or modifying the airflow system.
5.2 Periodically perform requalification to ensure that the system continues to perform as expected and remains in compliance with regulatory requirements.

5) Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• SOP: Standard Operating Procedure

6) Documents

• IQ/OQ/PQ Protocol
• Equipment Manufacturer Specifications
• Installation and Setup Reports
• Calibration Records
• Airflow and Pressure Logs
• Microbial Testing Logs
• Deviation and Corrective Action Reports

7) Reference

• FDA Guidance for Industry: Equipment Qualification
• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ISO 9001: Quality Management Systems – Requirements
• USP Chapter 1151: Pharmaceutical Dosage Forms

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: IQ/OQ/PQ Test Record

Date	Time	Operator Initials	Test Type (IQ/OQ/PQ)	Test Results	Comments
DD/MM/YYYY	HH:MM	Operator Name	IQ/OQ/PQ	Pass/Fail	Comments

Template 2: Airflow and Pressure Log

Batch No.	Test Date	Airflow Velocity (m/s)	Pressure (Pa)	Microbial Load (CFU/m³)	Operator Initials
Batch Number	DD/MM/YYYY	Airflow Velocity	Pressure	Microbial Load	Operator Name

Template 3: Microbial Testing Log

Batch No.	Test Date	Microbial Load (CFU/m³)	Pass/Fail	Operator Initials
Batch Number	DD/MM/YYYY	Microbial Load	Pass/Fail	Operator Name