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