Standard Operating Procedure for Emergency Exit and Fire Drill Plan at Clinical Site in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/103/2025
Supersedes	SOP/BA-BE/103/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the standard protocol for safe evacuation and conduct of fire drills at the clinical site conducting Bioavailability/Bioequivalence (BA/BE) studies, ensuring preparedness for emergencies and minimizing risks to volunteers and staff.

2. Scope

This SOP applies to all clinical staff, security personnel, facility engineers, and volunteers present at the clinical research unit during the execution of BA/BE studies.

3. Responsibilities

• Safety Officer: Leads emergency preparedness programs and conducts fire drills.
• Facility Engineer: Maintains emergency exits, fire extinguishers, alarms, and power backup systems.
• Clinical Research Coordinator (CRC): Guides volunteers to safety during drills and real emergencies.
• Principal Investigator (PI): Oversees overall safety strategy and ensures all staff are trained in evacuation procedures.

4. Accountability

The Head of Operations is accountable for ensuring the effectiveness of the emergency exit and fire drill plan, including infrastructure readiness and staff training.

5. Procedure

5.1 Emergency Exit Infrastructure

1. Ensure emergency exit maps are displayed in all clinical areas and volunteer rooms (see Annexure-1).
2. Emergency exits shall:
   • Remain unobstructed at all times
   • Be clearly illuminated with signage
   • Be accessible without keys or access cards

5.2 Fire Safety Equipment

1. Equip the facility with:
   • Fire extinguishers (ABC type)
   • Smoke detectors and alarms
   • Sprinkler systems in high-risk areas
2. Inspect equipment monthly and record in Annexure-2: Fire Safety Equipment Inspection Log.

5.3 Fire Drill Planning

1. Conduct at least two full-scale fire drills per year.
2. Drill must simulate realistic evacuation scenarios and involve:
   • Clinical and administrative staff
   • Volunteers (if present)
   • Security and emergency teams
3. Document in Annexure-3: Fire Drill Execution Record.

5.4 Actual Emergency Evacuation Procedure

1. Upon fire alarm:
   • CRC and nurses escort volunteers toward designated exits
   • Security guides traffic to safe zones
   • PI or designee confirms area clearance
2. Assemble at pre-identified muster point (see Annexure-4: Muster Point Attendance Log).
3. Account for all staff and subjects immediately after evacuation.

5.5 Post-Drill/Incident Review

1. Conduct debrief meeting with all teams.
2. Prepare CAPA for gaps identified during the drill or actual emergency (Annexure-5).

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• CAPA: Corrective and Preventive Action
• PI: Principal Investigator

7. Documents

1. Emergency Exit Layout Map – Annexure-1
2. Fire Safety Equipment Inspection Log – Annexure-2
3. Fire Drill Execution Record – Annexure-3
4. Muster Point Attendance Log – Annexure-4
5. Fire Drill CAPA Form – Annexure-5

8. References

• National Building Code of India
• ICH E6(R2) – Good Clinical Practice
• Local Fire Department 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: Emergency Exit Layout Map

[Insert building plan with exits marked]

Annexure-2: Fire Safety Equipment Inspection Log

Date	Location	Equipment	Status	Inspected By
10/04/2025	Dosing Room	ABC Extinguisher	OK	Ravi Nair

Annexure-3: Fire Drill Execution Record

Date	Drill Start Time	Evacuation Time	No. of Staff	No. of Subjects	Remarks
15/03/2025	11:00 AM	5 min	18	12	Successful

Annexure-4: Muster Point Attendance Log

Name	Role	Present	Signature
Sunita Reddy	CRC	Yes	Signed

Annexure-5: Fire Drill CAPA Form

Observation	Root Cause	Corrective Action	Preventive Action	Owner
Exit blocked by cart	Improper housekeeping	Cart removed	Monthly check protocol added	Facility Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	Site Setup	QA Head
17/04/2025	2.0	Annexures and evacuation timing added	Safety Enhancement	QA Head