SOP Guide for Pharma

SOP for Material Handling in Case of Emergency or Power Failure in Quarantine – V 2.0

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SOP for Material Handling in Case of Emergency or Power Failure in Quarantine – V 2.0

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

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.

See also  SOP for Assigning Goods Receipt Note (GRN) Number to Received Materials - V 2.0

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.
See also  SOP for Receiving Temperature-Sensitive Raw Materials - V 2.0

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

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

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department
See also  SOP for Quarantine Area Entry Restrictions and Security Measures - V 2.0

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
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