SOP Guide for Pharma

SOP for Managing Storage of Raw Materials in Emergency Situations – V 2.0

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SOP for Managing Storage of Raw Materials in Emergency Situations – V 2.0

Standard Operating Procedure for Managing Storage of Raw Materials in Emergency Situations

Department Warehouse / Quality Assurance / Safety
SOP No. SOP/RM/181/2025
Supersedes SOP/RM/181/2022
Page No. Page 1 of 15
Issue Date 16/04/2025
Effective Date 23/04/2025
Review Date 16/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the processes for managing the storage of raw materials during emergency situations, such as natural disasters, fires, chemical spills, and other unforeseen events. The goal is to protect raw materials from contamination, degradation, or loss and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, quality assurance (QA), and safety personnel involved in the emergency handling and storage of raw materials at the facility.

3. Responsibilities

  • Warehouse Personnel: Execute emergency protocols for the safe storage and protection of raw materials during emergencies.
  • Quality Assurance (QA) Team: Assess potential quality impacts on materials post-emergency and ensure compliance with GMP requirements.
  • Safety Team: Coordinate emergency responses and ensure safety protocols are followed.

4. Accountability

The Warehouse Manager is accountable for the secure storage of raw materials during emergencies, while the QA Manager is responsible for assessing the integrity

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