Standard Operating Procedure for HVAC System Monitoring

1) Purpose

This SOP outlines the procedures for monitoring Heating, Ventilation, and Air Conditioning (HVAC) systems in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to the monitoring of HVAC systems throughout the pharmaceutical manufacturing facility to ensure compliance with environmental control requirements.

3) Responsibilities

The Facilities or Engineering department is responsible for monitoring HVAC systems. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Routine Monitoring

1. Establish a schedule for routine monitoring of HVAC system parameters (e.g., temperature, humidity, pressure differentials).
2. Use calibrated instruments to measure and record HVAC parameters at specified locations within the facility.

4.2 Alarm Monitoring

1. Configure alarms for critical HVAC parameters (e.g., temperature excursions, pressure differentials) based on established limits.
2. Ensure alarms are functional and can alert personnel promptly in case of deviations.

4.3 Equipment Checks

1. Regularly inspect HVAC equipment (e.g., filters, fans, ductwork) for cleanliness, integrity, and proper functioning.
2. Perform preventive maintenance tasks as per schedule and document all maintenance activities.

4.4 Environmental Monitoring

1. Integrate HVAC system monitoring with environmental monitoring programs to ensure environmental control in critical areas (e.g., cleanrooms).
2. Review and analyze environmental monitoring data to identify trends and take corrective actions if necessary.

4.5 Documentation

1. Document all HVAC system monitoring activities, including measurements, alarms, and maintenance records, in designated logbooks or electronic systems.
2. Generate monitoring reports summarizing findings, trends, and any corrective actions implemented.
3. Review and approve monitoring reports to ensure compliance with regulatory requirements and internal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
HVAC: Heating, Ventilation, and Air Conditioning
QA: Quality Assurance

6) Documents, if any

HVAC System Monitoring Protocol, Monitoring Records, Monitoring Reports, Maintenance Records

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, ISO 14644 Cleanrooms and associated controlled environments, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0