of materials post-incident. The Safety Officer is responsible for ensuring all emergency procedures are correctly followed.

5. Procedure

5.1 Preparedness and Preventive Measures

1. Emergency Preparedness Plan:
   • Develop and maintain an Emergency Preparedness Plan for different types of emergencies (fire, flood, power outage, etc.).
   • Document the plan in the Emergency Preparedness Log (Annexure-1).
2. Emergency Contact List:
   • Maintain a list of emergency contacts, including warehouse, QA, maintenance, and local emergency services.
   • Store the contact list in the Emergency Contact Log (Annexure-2).
3. Training and Drills:
   • Conduct regular training and mock drills for warehouse personnel on emergency response procedures.
   • Document training and drills in the Emergency Drill Log (Annexure-3).

5.2 Emergency Response Procedures

1. Immediate Response:
   • Upon detection of an emergency, activate the facility’s emergency alarm system and notify the emergency response team.
   • Follow evacuation or containment procedures as per the Emergency Preparedness Plan.
   • Document the emergency event in the Emergency Incident Log (Annexure-4).
2. Protection of Raw Materials:
   • Relocate raw materials to designated safe storage areas if possible.
   • Use protective coverings (e.g., plastic sheeting) to shield materials from environmental exposure.
   • Record relocation activities in the Material Relocation Log (Annexure-5).

5.3 Post-Emergency Procedures

1. Damage Assessment:
   • The QA team must inspect raw materials for contamination, damage, or quality degradation.
   • Document assessments in the Post-Emergency Material Assessment Log (Annexure-6).
2. Material Disposition:
   • Decide on the disposition of affected materials (approve for use, quarantine, or dispose) based on QA assessment.
   • Record decisions in the Material Disposition Log (Annexure-7).

5.4 Corrective and Preventive Actions

1. Root Cause Analysis:
   • Identify the root cause of any failures in emergency response procedures and implement corrective actions.
   • Document findings in the Root Cause Analysis Log (Annexure-8).
2. Review and Update of Emergency Plans:
   • Review emergency response procedures regularly and update them based on lessons learned from actual events.
   • Document updates in the Emergency Plan Review Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• EHS: Environmental, Health, and Safety

7. Documents

1. Emergency Preparedness Log (Annexure-1)
2. Emergency Contact Log (Annexure-2)
3. Emergency Drill Log (Annexure-3)
4. Emergency Incident Log (Annexure-4)
5. Material Relocation Log (Annexure-5)
6. Post-Emergency Material Assessment Log (Annexure-6)
7. Material Disposition Log (Annexure-7)
8. Root Cause Analysis Log (Annexure-8)
9. Emergency Plan Review Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Good Storage Practices for Pharmaceuticals
• OSHA Guidelines on Emergency Preparedness and Response

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Emergency Preparedness Log

Date	Emergency Type	Preparedness Plan Reviewed	Reviewed By
16/04/2025	Flood	Plan Reviewed and Updated	Ravi Kumar

Annexure-2: Emergency Contact Log

Name	Department	Contact Number	Role
Neha Verma	Quality Assurance	+91-9876543210	QA Manager

Annexure-3: Emergency Drill Log

Date	Drill Type	Participants	Outcome
16/04/2025	Fire Drill	Warehouse Team	Successful

Annexure-4: Emergency Incident Log

Date	Incident Description	Response Action	Reported By
16/04/2025	Power Outage	Backup Power Activated	Amit Joshi

Annexure-5: Material Relocation Log

Date	Material Name	Relocation Area	Relocated By
16/04/2025	API X	Emergency Storage Unit	Priya Singh

Annexure-6: Post-Emergency Material Assessment Log

Date	Material Name	Assessment Result	Checked By
16/04/2025	API X	No Impact Detected	Kiran Patel

Annexure-7: Material Disposition Log

Date	Material Name	Disposition	Approved By
16/04/2025	API Y	Quarantined	QA Manager

Annexure-8: Root Cause Analysis Log

Date	Incident Description	Root Cause Identified	Analyzed By
16/04/2025	Delayed Response to Flood	Lack of Updated Emergency Plan	QA Supervisor

Annexure-9: Emergency Plan Review Log

Date	Plan Reviewed	Updates Made	Reviewed By
16/04/2025	Flood Preparedness Plan	Added Evacuation Routes	Sanjay Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
16/04/2025	2.0	Updated emergency response procedures and documentation.	Regulatory Update	QA Head