SOP Guide for Pharma

SOP for Proper Airflow and Ventilation in Raw Material Warehouses – V 2.0

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SOP for Proper Airflow and Ventilation in Raw Material Warehouses – V 2.0

Standard Operating Procedure for Proper Airflow and Ventilation in Raw Material Warehouses

Department Warehouse / Quality Assurance / Maintenance
SOP No. SOP/RM/139/2025
Supersedes SOP/RM/139/2022
Page No. Page 1 of 15
Issue Date 08/03/2025
Effective Date 15/03/2025
Review Date 08/03/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process to ensure proper airflow and ventilation in raw material warehouses to maintain material quality and prevent contamination, moisture buildup, and degradation in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw material storage areas, including zones for Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals within the warehouse facility.

3. Responsibilities

  • Warehouse Personnel: Monitor airflow conditions and report any irregularities.
  • Maintenance Team: Ensure ventilation systems are functioning optimally and conduct scheduled maintenance.
  • Warehouse Manager: Supervise the monitoring and maintenance of ventilation systems.
  • Quality Assurance (QA): Review ventilation records and ensure compliance with regulatory requirements.

4. Accountability

The Warehouse Manager is accountable for ensuring proper airflow and ventilation in all raw material storage areas. The QA Manager is responsible for verifying compliance with GMP and regulatory standards.

5. Procedure

5.1 Ventilation System Setup and Maintenance

  1. Initial Ventilation Setup:
    • Ensure the warehouse is equipped with HVAC systems capable of maintaining specified airflow rates and temperature control.
    • Install HEPA filters and exhaust fans in areas storing sensitive materials like APIs and solvents.
    • Document the initial system setup in the Ventilation System Setup Log (Annexure-1).
  2. Scheduled Maintenance:
    • Perform routine maintenance of ventilation systems, including filter replacement, fan inspections, and duct cleaning every three months.
    • Document maintenance activities in the Ventilation Maintenance Log (Annexure-2).
See also  SOP for Inspection and Receiving of Highly Potent Raw Materials - V 2.0

5.2 Monitoring of Airflow and Ventilation

  1. Daily Monitoring:
    • Warehouse personnel should check airflow levels daily using anemometers or automated sensors.
    • Ensure that airflow meets specified standards (e.g., 15-20 air changes per hour).
    • Record readings in the Daily Airflow Monitoring Log (Annexure-3).
  2. Humidity and Temperature Control:
    • Ensure that humidity is maintained below 60% and temperature within the recommended range for specific raw materials.
    • Monitor environmental data through automated systems and cross-verify manually once a week.
    • Document in the Temperature and Humidity Control Log (Annexure-4).

5.3 Handling Deviations in Airflow or Ventilation

  1. Identifying Deviations:
    • Identify any fluctuations in airflow, temperature, or humidity beyond acceptable limits.
    • Immediately report deviations to the Warehouse Manager and initiate corrective actions.
    • Record deviations in the Ventilation Deviation Log (Annexure-5).
  2. Corrective and Preventive Actions (CAPA):
    • Conduct root cause analysis to determine the cause of airflow issues.
    • Implement corrective measures such as adjusting HVAC settings, replacing faulty equipment, or sealing air leaks.
    • Document corrective actions in the Corrective Action Log (Annexure-6).

5.4 Documentation and Review

  1. Record Maintenance:
    • All records related to airflow and ventilation monitoring, deviations, and corrective actions must be retained for a minimum of five years.
    • Ensure all documents are readily available for audits and inspections.
    • Record details in the Record Retention Log (Annexure-7).
  2. Quarterly Review:
    • QA shall conduct a quarterly review of ventilation performance and suggest improvements if necessary.
    • Document findings and recommendations in the Ventilation Review Log (Annexure-8).
See also  SOP for Handling and Storing Documents Related to Raw Material Receiving - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • HVAC: Heating, Ventilation, and Air Conditioning
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Ventilation System Setup Log (Annexure-1)
  2. Ventilation Maintenance Log (Annexure-2)
  3. Daily Airflow Monitoring Log (Annexure-3)
  4. Temperature and Humidity Control Log (Annexure-4)
  5. Ventilation Deviation Log (Annexure-5)
  6. Corrective Action Log (Annexure-6)
  7. Record Retention Log (Annexure-7)
  8. Ventilation Review Log (Annexure-8)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO GMP Guidelines
  • 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
Department

11. Annexures

Annexure-1: Ventilation System Setup Log

Date System Installed Location Specifications Installed By
08/03/2025 HVAC with HEPA Filters API Storage Area 15 Air Changes/Hour, 22°C Amit Joshi

Annexure-2: Ventilation Maintenance Log

Date Maintenance Activity System Serviced Performed By Verified By
08/03/2025 Filter Replacement HEPA Filter – Zone A Ravi Kumar Priya Singh (QA)

Annexure-3: Daily Airflow Monitoring Log

Date Location Airflow Reading (CFM) Standard Airflow Status Checked By
08/03/2025 API Storage Room 350 CFM 350-400 CFM Within Limits Ravi Kumar
08/03/2025 Solvent Storage Area 300 CFM 350-400 CFM Below Limits Neha Verma

See also  SOP for Monitoring and Evaluating Supplier Performance in Raw Material Delivery - V 2.0

Annexure-4: Temperature and Humidity Control Log

Date Location Temperature (°C) Humidity (%) Standard Range Status Checked By
08/03/2025 API Storage Room 22°C 45% 20-25°C, <60% Within Limits Amit Joshi
08/03/2025 Solvent Storage Area 28°C 65% 20-25°C, <60% Out of Range Ravi Kumar

Annexure-5: Ventilation Deviation Log

Date Location Deviation Observed Possible Cause Reported By
08/03/2025 Solvent Storage Area Airflow below standard Clogged air filters Neha Verma
08/03/2025 API Storage Room Humidity above 60% HVAC malfunction Ravi Kumar

Annexure-6: Corrective Action Log

Date Deviation Description Corrective Action Taken Performed By Verified By
08/03/2025 Airflow below limits in Solvent Area Replaced air filters Amit Joshi Priya Singh (QA)
08/03/2025 Humidity out of range in API Storage Repaired HVAC system Ravi Kumar Rajeev Menon (QA)

Annexure-7: Record Retention Log

Date Document Name Retention Period Stored By Storage Location
08/03/2025 Daily Airflow Monitoring Log 5 Years Priya Singh (QA) Document Control Room A
08/03/2025 Ventilation Deviation Log 5 Years Rajeev Menon (QA) Document Control Room B

Annexure-8: Ventilation Review Log

Date Review Type Findings Recommendations Reviewed By
08/03/2025 Quarterly Review Clogged filters caused airflow issues Increase filter maintenance to monthly Priya Singh (QA)
08/03/2025 Annual Review Humidity fluctuations in API Storage Install additional dehumidifiers Rajeev Menon (QA)

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
08/03/2025 2.0 Added detailed monitoring procedures for airflow and humidity Compliance with updated GMP guidelines QA Head
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