The QA Manager ensures compliance with regulatory standards through regular audits.

5. Procedure

5.1 Air Circulation System Setup

1. HVAC System Requirements:
   • Ensure HVAC systems are designed to maintain consistent airflow, temperature, and humidity across storage areas.
   • Air filters must be of pharmaceutical-grade HEPA filters and replaced regularly.
   • Document system setup and configuration in the Air Circulation System Setup Log (Annexure-1).
2. Ventilation and Airflow Design:
   • Air vents should be strategically positioned to cover the entire storage space, ensuring no dead zones.
   • Maintain a clearance of at least 12 inches from walls and vents to facilitate proper airflow.

5.2 Monitoring and Measuring Air Circulation

1. Airflow Monitoring Tools:
   • Use calibrated anemometers to measure airflow velocity and direction at multiple points in storage areas.
   • Perform airflow tests monthly or after any significant maintenance or system changes.
   • Document measurements in the Airflow Monitoring Log (Annexure-2).
2. Environmental Monitoring:
   • Temperature and humidity sensors should be placed at various heights and locations to detect airflow inconsistencies.
   • Record environmental conditions daily in the Environmental Monitoring Log (Annexure-3).

5.3 Material Arrangement for Optimal Airflow

1. Placement Guidelines:
   • Do not block air vents with materials or shelving units.
   • Ensure materials are stored on pallets with adequate space between rows for air to circulate.
   • Maintain at least 6 inches of space between materials and the floor to prevent airflow obstruction.
   • Document storage arrangement audits in the Material Placement Audit Log (Annexure-4).

5.4 Maintenance of Air Circulation Systems

1. Preventive Maintenance Schedule:
   • Schedule monthly inspections and quarterly maintenance of HVAC systems, including filter replacements and duct cleaning.
   • Document all maintenance activities in the Air Circulation Maintenance Log (Annexure-5).
2. Filter Replacement and Cleaning:
   • Replace HEPA filters every 6 months or as recommended by the manufacturer.
   • Document filter changes in the Filter Replacement Log (Annexure-6).

5.5 Handling Air Circulation Deviations

1. Deviation Identification and Reporting:
   • Identify deviations such as inconsistent airflow, stagnant air zones, or temperature/humidity fluctuations.
   • Report deviations immediately to the Maintenance Team and document them in the Air Circulation Deviation Log (Annexure-7).
2. Corrective Actions:
   • Adjust airflow systems, replace faulty components, or rearrange materials to restore proper circulation.
   • Document corrective actions in the Air Circulation Corrective Action Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• HVAC: Heating, Ventilation, and Air Conditioning
• HEPA: High-Efficiency Particulate Air

7. Documents

1. Air Circulation System Setup Log (Annexure-1)
2. Airflow Monitoring Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. Material Placement Audit Log (Annexure-4)
5. Air Circulation Maintenance Log (Annexure-5)
6. Filter Replacement Log (Annexure-6)
7. Air Circulation Deviation Log (Annexure-7)
8. Air Circulation Corrective Action Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Air Circulation System Setup Log

Date	System Component	Setup Details	Configured By
03/04/2025	HVAC Unit A	Installed with HEPA filters	Ravi Kumar
03/04/2025	Ventilation Duct B	Positioned for uniform airflow	Neha Verma

Annexure-2: Airflow Monitoring Log

Date	Storage Area	Airflow Reading (m/s)	Measured By
03/04/2025	Aisle 1	0.45 m/s	Priya Singh
03/04/2025	Aisle 2	0.50 m/s	Amit Joshi

Annexure-3: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Checked By
03/04/2025	Aisle 1	22°C	45%	Neha Verma
03/04/2025	Aisle 2	21°C	50%	Ravi Kumar

Annexure-4: Material Placement Audit Log

Date	Storage Area	Audit Findings	Audited By
03/04/2025	Aisle 1	Materials placed correctly, vents clear	Amit Joshi
03/04/2025	Aisle 2	Blocked vent identified, corrected	Priya Singh

Annexure-5: Air Circulation Maintenance Log

Date	System Component	Maintenance Activity	Performed By
03/04/2025	HVAC Unit A	Filter cleaned	Ravi Kumar
03/04/2025	Ventilation Duct B	Duct cleaned and inspected	Neha Verma

Annexure-6: Filter Replacement Log

Date	Filter Type	Location	Replaced By
03/04/2025	HEPA	HVAC Unit A	Amit Joshi

Annexure-7: Air Circulation Deviation Log

Date	Deviation Description	Reported By	Storage Area
03/04/2025	Low airflow detected in Aisle 2	Priya Singh	Aisle 2

Annexure-8: Air Circulation Corrective Action Log

Date	Corrective Action Taken	Performed By	Verified By
03/04/2025	Cleared blockage and adjusted airflow	Amit Joshi	QA Team

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
03/04/2025	2.0	Updated air circulation monitoring procedures	Enhanced Compliance	QA Head