Standard Operating Procedure for Contingency Plan for Power or Equipment Failure in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/102/2025 |
| Supersedes | SOP/BA-BE/102/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a contingency plan for managing power outages or equipment malfunctions during the clinical phase of BA/BE studies, thereby ensuring subject safety, sample integrity, and uninterrupted data collection.
2. Scope
This SOP applies to all clinical personnel, facility managers, and technical teams involved in operating, monitoring, and maintaining equipment or systems supporting the clinical phase of BA/BE studies.
3. Responsibilities
- Facility Engineer: Ensures power backup systems and emergency equipment are in functional condition.
- QA Officer: Verifies and audits contingency preparedness documentation and implementation.
- Study Nurse / CRC: Monitors subject safety during interruptions and documents all actions taken.
- Principal Investigator (PI): Oversees subject protection and study continuation decisions during failures.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that the contingency procedures are in place, tested periodically, and followed strictly during actual events.
5. Procedure
5.1 Preventive Measures
- All critical equipment (freezers, centrifuges, ECG, dosing area lights, data systems) must be connected to UPS or diesel generator backup.
- Backup power systems to be tested monthly (see Annexure-1: Power Backup Test Log).
- Spare equipment (e.g., manual stopwatch, backup centrifuge) should be available.
5.2 Identification of Power or Equipment Failure
- In case of failure, the person identifying it must:
- Immediately notify Facility Engineer
- Inform PI and QA
- Document the time and nature of failure (Annexure-2)
5.3 Clinical Continuity Protocol
- If dosing or sample collection is ongoing:
- Switch to manual methods where possible (e.g., stopwatch, manual labels)
- Ensure subject safety—relocate to ventilated or cooler area if required
- Document fallback procedures used in Annexure-3: Clinical Continuity Log.
5.4 Sample and Equipment Integrity
- Verify temperature logs of sample storage devices.
- Transfer samples to alternative freezers if backup fails.
- QA to assess and log impact of equipment failure on sample/data integrity (Annexure-4).
5.5 Restoration and Follow-Up
- Record restoration time and activities in Annexure-5: Incident Resolution Record.
- Initiate CAPA in case of critical deviations or non-recoverable data/sample loss.
- Inform sponsor and document in Deviation/Incident Report.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- QA: Quality Assurance
- PI: Principal Investigator
- UPS: Uninterruptible Power Supply
- CAPA: Corrective and Preventive Action
7. Documents
- Power Backup Test Log – Annexure-1
- Equipment/Power Failure Notification Form – Annexure-2
- Clinical Continuity Log – Annexure-3
- QA Impact Assessment Log – Annexure-4
- Incident Resolution Record – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- Indian GCP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Power Backup Test Log
| Date | System Tested | Duration | Tested By | Status |
|---|---|---|---|---|
| 10/04/2025 | Generator | 30 min | Ravi Nair | Pass |
Annexure-2: Equipment/Power Failure Notification
| Date/Time | Nature of Failure | Identified By | Immediate Action |
|---|---|---|---|
| 17/04/2025, 07:15 AM | Freezer power loss | Sunita Reddy | Switched to UPS |
Annexure-3: Clinical Continuity Log
| Subject ID | Activity | Backup Action | Time Logged | Observer |
|---|---|---|---|---|
| VOL-102 | Blood Draw | Manual stopwatch used | 07:20 AM | CRC |
Annexure-4: QA Impact Assessment Log
| Date | Impact Area | Assessment Summary | Action Required | QA Reviewer |
|---|---|---|---|---|
| 17/04/2025 | Sample Stability | No thawing observed | None | QA Officer |
Annexure-5: Incident Resolution Record
| Date/Time | Restoration Action | Resolved By | Verified By |
|---|---|---|---|
| 17/04/2025, 08:00 AM | Power Restored | Facility Engineer | QA Officer |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | System Implementation | QA Head |
| 17/04/2025 | 2.0 | Annexures added and aligned to risk management plan | Audit Compliance | QA Head |