Manager is accountable for ensuring all storage equipment undergoes regular preventive maintenance as per this SOP. The Warehouse Manager is responsible for coordinating maintenance activities, while the QA Manager ensures compliance through audits and documentation reviews.

5. Procedure

5.1 Preventive Maintenance Schedule

1. Development of Maintenance Schedule:
   • Develop a preventive maintenance schedule based on manufacturer recommendations, equipment usage, and criticality.
   • Ensure the schedule includes daily, weekly, monthly, quarterly, and annual maintenance tasks.
   • Document the schedule in the Preventive Maintenance Schedule Log (Annexure-1).
2. Communication of Schedule:
   • Display the maintenance schedule in the maintenance and warehouse areas.
   • Ensure all relevant personnel are aware of their responsibilities regarding maintenance activities.

5.2 Equipment Maintenance Procedures

1. Shelving Units:
   • Inspect shelving units monthly for structural integrity, rust, and cleanliness.
   • Tighten loose bolts, replace damaged shelves, and apply rust-proof coatings as needed.
   • Document activities in the Shelving Maintenance Log (Annexure-2).
2. Temperature and Humidity Control Devices:
   • Calibrate thermometers and hygrometers quarterly to ensure accurate readings.
   • Clean and inspect HVAC and refrigeration units monthly to ensure efficient performance.
   • Document maintenance activities in the Temperature and Humidity Device Maintenance Log (Annexure-3).
3. Safety Equipment:
   • Inspect fire extinguishers, alarms, and emergency lighting systems monthly for functionality.
   • Replace expired fire extinguishers and test alarms as per manufacturer guidelines.
   • Document safety equipment maintenance in the Safety Equipment Maintenance Log (Annexure-4).

5.3 Documentation and Verification

1. Maintenance Records:
   • Complete detailed records for all maintenance activities, including the date, type of maintenance, issues identified, corrective actions taken, and the name of the person performing the maintenance.
   • Store maintenance records securely and ensure they are accessible for audits and reviews.
2. Verification and Audits:
   • The QA team must conduct quarterly audits of maintenance records and verify that preventive maintenance is performed according to the schedule.
   • Document audit findings in the Maintenance Audit Log (Annexure-5).

5.4 Handling Equipment Malfunctions and Repairs

1. Reporting and Documentation:
   • Any equipment malfunction must be reported immediately to the Maintenance Manager.
   • Document malfunctions in the Equipment Malfunction Report (Annexure-6).
2. Corrective Actions and Repairs:
   • Conduct repairs promptly and ensure corrective actions prevent recurrence of the issue.
   • Document repairs and corrective actions in the Corrective Maintenance Log (Annexure-7).
3. Post-Repair Verification:
   • Verify the functionality of repaired equipment and document the verification process in the Post-Repair Verification Log (Annexure-8).

6. Abbreviations

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

7. Documents

1. Preventive Maintenance Schedule Log (Annexure-1)
2. Shelving Maintenance Log (Annexure-2)
3. Temperature and Humidity Device Maintenance Log (Annexure-3)
4. Safety Equipment Maintenance Log (Annexure-4)
5. Maintenance Audit Log (Annexure-5)
6. Equipment Malfunction Report (Annexure-6)
7. Corrective Maintenance Log (Annexure-7)
8. Post-Repair Verification 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: Preventive Maintenance Schedule Log

Date	Equipment	Maintenance Task	Frequency	Scheduled By
02/04/2025	HVAC System	Filter Cleaning	Monthly	Ravi Kumar
02/04/2025	Shelving Units	Structural Inspection	Quarterly	Neha Verma

Annexure-2: Shelving Maintenance Log

Date	Shelf Location	Maintenance Performed	Performed By
02/04/2025	Aisle 1, Shelf A	Replaced damaged shelf panel	Amit Joshi

Annexure-3: Temperature and Humidity Device Maintenance Log

Date	Device Location	Maintenance Task	Performed By
02/04/2025	Warehouse Zone A	Calibrated Hygrometer	Priya Singh

Annexure-4: Safety Equipment Maintenance Log

Date	Equipment	Maintenance Task	Performed By
02/04/2025	Fire Alarm System	Battery Replacement	Ravi Kumar

Annexure-5: Maintenance Audit Log

Date	Auditor Name	Audit Findings	Corrective Actions Required
02/04/2025	QA Manager	All records in compliance	None

Annexure-6: Equipment Malfunction Report

Date	Equipment	Issue Identified	Reported By
02/04/2025	Refrigeration Unit	Temperature fluctuation detected	Neha Verma

Annexure-7: Corrective Maintenance Log

Date	Equipment	Corrective Action Taken	Performed By
02/04/2025	Refrigeration Unit	Replaced faulty thermostat	Amit Joshi

Annexure-8: Post-Repair Verification Log

Date	Equipment	Verification Result	Verified By
02/04/2025	Refrigeration Unit	Functioning within acceptable range	Priya Singh

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
02/04/2025	2.0	Included Post-Repair Verification Procedures	Enhance Equipment Reliability	QA Head