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

1. All critical equipment (freezers, centrifuges, ECG, dosing area lights, data systems) must be connected to UPS or diesel generator backup.
2. Backup power systems to be tested monthly (see Annexure-1: Power Backup Test Log).
3. Spare equipment (e.g., manual stopwatch, backup centrifuge) should be available.

5.2 Identification of Power or Equipment Failure

1. 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

1. 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
2. Document fallback procedures used in Annexure-3: Clinical Continuity Log.

5.4 Sample and Equipment Integrity

1. Verify temperature logs of sample storage devices.
2. Transfer samples to alternative freezers if backup fails.
3. QA to assess and log impact of equipment failure on sample/data integrity (Annexure-4).

5.5 Restoration and Follow-Up

1. Record restoration time and activities in Annexure-5: Incident Resolution Record.
2. Initiate CAPA in case of critical deviations or non-recoverable data/sample loss.
3. 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

1. Power Backup Test Log – Annexure-1
2. Equipment/Power Failure Notification Form – Annexure-2
3. Clinical Continuity Log – Annexure-3
4. QA Impact Assessment Log – Annexure-4
5. 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