Standard Operating Procedure for Preventive Maintenance of Clinical Equipment in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/116/2025 |
| Supersedes | SOP/BA-BE/116/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for the scheduling, execution, and documentation of preventive maintenance for clinical equipment used in the conduct of Bioavailability/Bioequivalence (BA/BE) studies to ensure operational readiness and compliance with regulatory standards.
2. Scope
This SOP is applicable to all clinical equipment including but not limited to ECG machines, centrifuges, freezers, refrigerators, blood pressure monitors, weighing balances, and
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
- Maintain a master list of clinical equipment with:
- Equipment name
- Model number
- Location
- Serial number
- Develop a preventive maintenance schedule based on:
- Manufacturer’s recommendation
- Usage frequency
- Criticality to study operations
- Document the plan using Annexure-1: Annual Maintenance Schedule.
5.2 Execution of Maintenance Activities
- Initiate maintenance as per planned schedule or before study initiation.
- Ensure the following steps are covered:
- Visual inspection
- Calibration (where applicable)
- Functional verification
- Cleaning and lubrication (as required)
- Complete Annexure-2: Preventive Maintenance Checklist for each equipment.
5.3 External Vendor Engagement
- Select vendors based on:
- Experience and certification
- Calibration traceability to national/international standards
- Obtain calibration certificates and attach them to Annexure-3: Equipment Service Record.
5.4 Deviation Handling and Repairs
- 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
- Attach:
- Checklists
- Service reports
- Calibration certificates
- File documents in the Equipment Qualification & Maintenance Folder.
- 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
- Annual Maintenance Schedule – Annexure-1
- Preventive Maintenance Checklist – Annexure-2
- Equipment Service Record – Annexure-3
- 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 |