emergency resuscitation kits used during BA/BE trials.

3. Responsibilities

• Maintenance Officer: Schedules preventive maintenance activities and performs internal checks or coordinates with vendors.
• QA Officer: Verifies maintenance logs and ensures regulatory compliance through periodic audits.
• Clinical Facility Coordinator: Ensures equipment is available, cleaned, and ready before scheduled maintenance.
• Vendor Technician: Performs calibration and maintenance as per manufacturer’s standards and signs service report.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that all clinical equipment is properly maintained and documented to prevent study disruptions and protect subject safety.

5. Procedure

5.1 Equipment Inventory and Maintenance Planning

1. Maintain a master list of clinical equipment with:
   • Equipment name
   • Model number
   • Location
   • Serial number
2. Develop a preventive maintenance schedule based on:
   • Manufacturer’s recommendation
   • Usage frequency
   • Criticality to study operations
3. Document the plan using Annexure-1: Annual Maintenance Schedule.

5.2 Execution of Maintenance Activities

1. Initiate maintenance as per planned schedule or before study initiation.
2. Ensure the following steps are covered:
   • Visual inspection
   • Calibration (where applicable)
   • Functional verification
   • Cleaning and lubrication (as required)
3. Complete Annexure-2: Preventive Maintenance Checklist for each equipment.

5.3 External Vendor Engagement

1. Select vendors based on:
   • Experience and certification
   • Calibration traceability to national/international standards
2. Obtain calibration certificates and attach them to Annexure-3: Equipment Service Record.

5.4 Deviation Handling and Repairs

1. If equipment is found out of specification:
   • Tag as “OUT OF ORDER” and remove from service
   • Document using Annexure-4: Equipment Breakdown Log
   • Initiate corrective action or replacement immediately

5.5 Post-Maintenance Documentation

1. Attach:
   • Checklists
   • Service reports
   • Calibration certificates
2. File documents in the Equipment Qualification & Maintenance Folder.
3. QA shall review and sign off post-maintenance records monthly.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• QA: Quality Assurance
• OOS: Out of Specification
• SOP: Standard Operating Procedure

7. Documents

1. Annual Maintenance Schedule – Annexure-1
2. Preventive Maintenance Checklist – Annexure-2
3. Equipment Service Record – Annexure-3
4. Equipment Breakdown Log – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO Technical Report Series on Clinical Site Requirements
• Manufacturer Equipment Manuals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Annual Maintenance Schedule

Equipment Name	Location	Frequency	Next Due Date
ECG Machine	Room 101	Quarterly	15/07/2025

Annexure-2: Preventive Maintenance Checklist

Equipment	Activity	Performed By	Date	Remarks
BP Monitor	Calibration	Rajesh Kumar	15/04/2025	OK

Annexure-3: Equipment Service Record

Equipment	Service Date	Vendor	Certificate Attached
Centrifuge	12/04/2025	ABC Biomedical	Yes

Annexure-4: Equipment Breakdown Log

Date	Equipment	Issue	Status	Corrective Action
10/04/2025	Refrigerator	Not cooling	Repaired	Compressor replaced

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Release	GCP Requirement	QA Head
17/04/2025	2.0	Added annexures and external vendor engagement criteria	Annual SOP Review	QA Head