Standard Operating Procedure for Handling and Movement of Quarantined Hazardous Raw Materials

Department	Warehouse / Quality Assurance / Safety
SOP No.	SOP/RM/066/2025
Supersedes	SOP/RM/066/2022
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 safe handling and movement of hazardous raw materials within the quarantine area to prevent contamination, ensure worker safety, and comply with Good Manufacturing Practices (GMP) and safety regulations.

2. Scope

This SOP applies to all hazardous raw materials, including flammable, toxic, corrosive, and reactive substances, that are stored in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

• Warehouse Personnel: Safely handle and transport hazardous raw materials following all safety protocols.
• Quality Assurance (QA): Ensure compliance with GMP and hazardous material handling standards.
• Safety Officer: Monitor handling procedures, provide training, and ensure proper use of personal protective equipment (PPE).
• Quality Control (QC): Conduct sampling and testing of hazardous materials in designated safe zones.

4. Accountability

The Warehouse Manager is responsible for ensuring hazardous materials are handled and stored correctly. The QA Manager ensures compliance with GMP standards, and the Safety Officer ensures that all personnel are trained and equipped for handling hazardous materials.

5. Procedure

5.1 Preparation for Handling Hazardous Materials

1. Personnel Training:
   • Ensure all personnel handling hazardous materials are trained in chemical safety, emergency response, and proper use of PPE.
   • Document training records in the Hazardous Material Training Log (Annexure-1).
2. PPE Requirements:
   • Personnel must wear appropriate PPE, including gloves, goggles, lab coats, face shields, and respirators (if required).
   • PPE must be inspected before use and replaced if damaged.

5.2 Handling Procedures for Hazardous Raw Materials

1. Labeling and Identification:
   • Ensure all hazardous materials are clearly labeled with hazard symbols, material names, batch numbers, and quarantine status.
   • Use color-coded labels to distinguish hazardous materials from non-hazardous ones.
2. Handling Instructions:
   • Handle materials gently to prevent spills or reactions. Avoid stacking containers unless specified as safe.
   • Use non-sparking tools and grounded equipment for flammable materials.
   • Maintain material safety data sheets (MSDS) accessible near the storage area.

5.3 Movement of Hazardous Raw Materials

1. Transporting Within the Quarantine Area:
   • Use flameproof, explosion-proof, or corrosion-resistant carts and equipment for moving hazardous materials.
   • Secure containers properly during transport to prevent tipping or leakage.
   • Follow designated pathways and avoid high-traffic areas to minimize exposure risk.
   • Document movement details in the Hazardous Material Movement Log (Annexure-2).
2. Segregation of Incompatible Materials:
   • Store and transport incompatible chemicals (e.g., acids and bases, oxidizers and organics) separately to prevent reactions.
   • Refer to the Chemical Compatibility Chart before moving materials.

5.4 Emergency Procedures

1. Spill Response:
   • In case of a spill, evacuate the area immediately and alert the Safety Officer.
   • Use spill kits designed for the specific type of hazardous material.
   • Document spill incidents in the Hazardous Spill Incident Report (Annexure-3).
2. Fire or Explosion Response:
   • Activate fire alarms and use appropriate fire extinguishers (e.g., Class B for flammable liquids).
   • Evacuate the area and follow the facility’s emergency response plan.
   • Document fire or explosion incidents in the Emergency Response Log (Annexure-4).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment
• MSDS: Material Safety Data Sheet

7. Documents

1. Hazardous Material Training Log (Annexure-1)
2. Hazardous Material Movement Log (Annexure-2)
3. Hazardous Spill Incident Report (Annexure-3)
4. Emergency Response Log (Annexure-4)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• 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: Hazardous Material Training Log

Date	Employee Name	Department	Training Type	Trainer Name	Remarks
01/02/2025	Ravi Kumar	Warehouse	Chemical Safety & PPE	Ajay Singh	Completed
01/02/2025	Sunita Sharma	QC	Hazardous Material Handling	Anjali Mehta	Completed

Annexure-2: Hazardous Material Movement Log

Date	Material Name	Batch Number	Moved From	Moved To	Moved By	Remarks
01/02/2025	Flammable Solvent-A	A-2025-001	Receiving Dock	Quarantine Zone E	Ramesh Patel	Moved Using Flameproof Cart

Annexure-3: Hazardous Spill Incident Report

Date	Material Name	Batch Number	Incident Description	Reported By	Corrective Action Taken
02/02/2025	Corrosive Chemical-B	B-2025-002	Minor Spill During Transfer	Sunita Sharma	Spill Contained Using Neutralizing Agent

Annexure-4: Emergency Response Log

Date	Incident	Response Action	Responded By	Remarks
03/02/2025	Fire Alarm Triggered	Evacuated Area, Fire Extinguisher Used	Ajay Singh	No Injury, Area Secured

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 Procedures and Handling Protocols	Regulatory Compliance	QA Head