Standard Operating Procedure for Material Handling in Case of Emergency or Power Failure in Quarantine

Department	Warehouse / Quality Assurance / Safety Management
SOP No.	SOP/RM/075/2025
Supersedes	SOP/RM/075/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the emergency procedures for handling quarantined raw materials during power failures, natural disasters, or other emergencies to maintain material integrity and ensure safety and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials stored in the quarantine area that may be affected during emergencies or power failures.

3. Responsibilities

• Warehouse Personnel: Implement emergency handling procedures and safeguard materials during power failures.
• Quality Assurance (QA): Monitor material conditions, authorize corrective actions, and ensure compliance with GMP.
• Safety Management Team: Oversee safety protocols and coordinate emergency response procedures.

4. Accountability

The Warehouse Manager is responsible for initiating emergency procedures. The QA Manager ensures the integrity of materials post-incident, and the Safety Manager is accountable for overall emergency preparedness and response.

5. Procedure

5.1 Emergency Preparedness

1. Risk Assessment:
   • Conduct periodic risk assessments to identify potential emergency scenarios affecting quarantined materials.
   • Document risk assessments in the Emergency Preparedness Log (Annexure-1).
2. Backup Systems:
   • Ensure backup power systems (generators, UPS) are installed and regularly tested for functionality.
   • Maintain an updated list of critical equipment and their power requirements.

5.2 Procedure During Power Failure

1. Initial Response:
   • Immediately notify the Warehouse Manager, QA Manager, and Safety Team of the power failure.
   • Activate emergency lighting and ensure access routes remain clear.
2. Material Protection:
   • For temperature-sensitive materials:
     • Transfer to backup refrigeration units if power is not restored within 30 minutes.
     • Use insulated containers for short-term storage if backup refrigeration is unavailable.
   • For non-temperature-sensitive materials:
     • Ensure containers remain sealed and labeled correctly.
     • Monitor for any physical damage or contamination risks.
   • Record material movements and conditions in the Emergency Material Handling Log (Annexure-2).

5.3 Post-Emergency Procedures

1. Material Inspection:
   • Once the emergency is resolved, inspect all materials for signs of degradation, contamination, or temperature excursions.
   • Document inspection findings in the Post-Emergency Material Inspection Log (Annexure-3).
2. QA Review:
   • QA must review the inspection records and determine if materials are still suitable for use.
   • Materials compromised during the emergency should be labeled as “Hold” and sent for additional testing or disposal.

5.4 Documentation and Reporting

1. Incident Reporting:
   • Prepare a detailed incident report, including:
     • Time and duration of the power failure
     • Materials affected
     • Actions taken
     • Final disposition of materials
   • Submit the report to QA and Safety Management for review and approval.
   • Document the report in the Emergency Incident Report Log (Annexure-4).
2. Corrective Actions:
   • Identify the root cause of the emergency and implement corrective actions to prevent recurrence.
   • Document corrective actions in the Corrective Action Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• UPS: Uninterruptible Power Supply

7. Documents

1. Emergency Preparedness Log (Annexure-1)
2. Emergency Material Handling Log (Annexure-2)
3. Post-Emergency Material Inspection Log (Annexure-3)
4. Emergency Incident Report Log (Annexure-4)
5. Corrective Action Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

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 Preparedness Log

Date	Emergency Type	Preparedness Measures	Conducted By	Verified By (QA)
01/01/2025	Power Failure	Backup Generators Tested	Ravi Kumar	Anjali Mehta

Annexure-2: Emergency Material Handling Log

Date	Material Name	Batch Number	Action Taken	Handled By	Verified By (QA)
01/02/2025	API-X	X-2025-001	Moved to Backup Refrigerator	Sunita Sharma	Ajay Singh

Annexure-3: Post-Emergency Material Inspection Log

Date	Material Name	Batch Number	Inspection Findings	Inspected By	QA Review
02/02/2025	API-X	X-2025-001	No Temperature Excursion	Ravi Kumar	Approved

Annexure-4: Emergency Incident Report Log

Date	Incident Description	Duration	Materials Affected	Actions Taken	Reported By
01/02/2025	Power Failure	2 Hours	API-X, Excipient-Y	Backup Systems Activated	Ajay Singh

Annexure-5: Corrective Action Log

Date	Issue	Corrective Action	Responsible Person	Follow-Up Required
03/02/2025	Delayed Generator Start	Generator Maintenance Scheduled	Sunita Sharma	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Emergency Handling Procedures	Regulatory Compliance	QA Head