performance qualification tests.

Manufacturing Department: Supports operational requirements and access to classified areas.

4. Accountability

The Head – Engineering Department is accountable for ensuring timely and compliant validation of HVAC systems in accordance with regulatory requirements and internal quality policies.

5. Procedure

5.1 Preparation of Validation Protocol

1. Prepare the HVAC validation protocol in accordance with site validation master plan (VMP).
2. Include system overview, risk assessment, test strategy, acceptance criteria, and schedule.
3. Get the protocol reviewed by QA and approved before execution.

5.2 Validation Tests

1. Airflow Velocity and Pattern Test: Verify laminar flow characteristics and directionality.
2. HEPA Filter Integrity Test: Conduct DOP or PAO testing to ensure filter efficiency.
3. Particle Count Test: Measure non-viable particulates per ISO Class guidelines.
4. Temperature and Humidity Mapping: Monitor parameters at predefined locations over a defined duration.
5. Differential Pressure Test: Confirm pressure gradients between classified areas.
6. Recovery Test: Measure system’s ability to return to acceptable limits after a disturbance.

5.3 Execution of Validation

1. Assign trained personnel to execute validation activities.
2. Use calibrated instruments with current calibration certificates.
3. Document observations, raw data, and deviations if any.

5.4 Report Preparation and Approval

1. Compile validation data and compare results with acceptance criteria.
2. Highlight any non-conformances and corrective actions taken.
3. Submit the report to QA for final review and approval.

5.5 Revalidation Criteria

1. Perform revalidation upon major equipment modification, relocation, or after maintenance affecting performance.
2. Revalidate every 3 years or as per risk assessment and regulatory expectations.

6. Abbreviations

• HVAC: Heating, Ventilation, and Air Conditioning
• HEPA: High Efficiency Particulate Air
• DOP: Dioctyl Phthalate
• PAO: Polyalphaolefin
• QA: Quality Assurance

7. Documents

1. HVAC Validation Protocol – Annexure-1
2. HVAC Validation Report – Annexure-2
3. Calibration Certificates of Instruments – Annexure-3

8. References

• WHO TRS 961 Annex 6: HVAC Systems – Design Qualification and Validation
• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• ISO 14644-1: Cleanrooms and associated controlled environments

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: HVAC Validation Protocol Format

Protocol No.
Location
System Description
Test Parameters
Acceptance Criteria
Execution Schedule
Prepared By
Reviewed By
Approved By

Annexure-2: HVAC Validation Report Template

Protocol No.
Date of Execution
Test Summary
Observations
Deviations Noted
Conclusion
Prepared By
Reviewed By
Approved By

Annexure-3: Calibration Certificate Register

Instrument Name	Make/Model	Serial No.	Calibration Due Date	Attached (Yes/No)

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
18/05/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Updated protocol and test formats	Routine revision	QA Head