raw materials. The QA Manager is responsible for verifying compliance with GMP and safety regulations.

5. Procedure

5.1 Identification and Classification of Water-Reactive Materials

1. Material Identification:
   • Water-reactive materials include substances such as Sodium, Potassium, Calcium Carbide, and Phosphorus Pentachloride.
   • Verify identification through the supplier’s Safety Data Sheets (SDS).
   • Document the identified materials in the Water-Reactive Material Identification Log (Annexure-1).
2. Classification:
   • Classify materials based on their reactivity:
     • Mild: Minimal reaction with water (e.g., Aluminum Chloride).
     • Moderate: Generates heat or fumes (e.g., Calcium Carbide).
     • Severe: Explosive reactions with water (e.g., Sodium).
   • Record classifications in the material log.

5.2 Storage Requirements

1. Designated Storage Areas:
   • Store materials in moisture-free, well-ventilated, and temperature-controlled areas.
   • Use airtight, corrosion-resistant containers to prevent moisture ingress.
   • Ensure storage locations are clearly labeled and isolated from other incompatible materials.
   • Document storage locations in the Water-Reactive Material Storage Log (Annexure-2).
2. Environmental Monitoring:
   • Monitor humidity and temperature regularly using calibrated instruments.
   • Ensure relative humidity remains below 30% unless specified otherwise in the SDS.
   • Document environmental data in the Environmental Monitoring Log (Annexure-3).

5.3 Handling Procedures

1. Personal Protective Equipment (PPE):
   • Personnel must wear chemical-resistant gloves, face shields, lab coats, and safety goggles when handling water-reactive materials.
   • Use appropriate respirators if handling materials that emit hazardous fumes.
   • Document PPE usage in the PPE Compliance Log (Annexure-4).
2. Safe Handling Practices:
   • Handle materials in dry areas with non-sparking tools.
   • Minimize exposure time and avoid transferring materials in humid conditions.
   • Document all handling procedures in the Material Handling Log (Annexure-5).

5.4 Spill and Emergency Procedures

1. Spill Response:
   • Evacuate the area immediately in case of spills.
   • Use inert materials like dry sand or vermiculite to contain spills. Do NOT use water.
   • Place contained materials in a designated hazardous waste container.
   • Document all spill incidents in the Spill Incident Log (Annexure-6).
2. Fire and Explosion Control:
   • In case of fire, use Class D fire extinguishers designed for metal fires.
   • Do not attempt to extinguish with water or water-based foam.
   • Ensure emergency contacts are notified immediately and record the incident in the Emergency Response Log (Annexure-7).

6. Abbreviations

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

7. Documents

1. Water-Reactive Material Identification Log (Annexure-1)
2. Water-Reactive Material Storage Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. PPE Compliance Log (Annexure-4)
5. Material Handling Log (Annexure-5)
6. Spill Incident Log (Annexure-6)
7. Emergency Response Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Standard for Hazardous Materials Handling (29 CFR 1910.1200)
• WHO Guidelines for the Safe Transport and Handling of Hazardous Chemicals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Water-Reactive Material Identification Log

Date	Material Name	Batch Number	Reactivity Level (Mild/Moderate/Severe)	Identified By
14/03/2025	Sodium	SOD-1234	Severe	Ravi Kumar
14/03/2025	Calcium Carbide	CCB-5678	Moderate	Neha Verma

Annexure-2: Water-Reactive Material Storage Log

Date	Material Name	Batch Number	Storage Location	Storage Conditions	Stored By
14/03/2025	Sodium	SOD-1234	Dry Storage Room A1	Temperature: 20°C, Humidity: <30%	Ravi Kumar
14/03/2025	Calcium Carbide	CCB-5678	Moisture-Controlled Cabinet B2	Temperature: 25°C, Humidity: <25%	Neha Verma

Annexure-3: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Status	Checked By
14/03/2025	Dry Storage Room A1	20°C	28%	Within Limits	Priya Singh
14/03/2025	Moisture-Controlled Cabinet B2	25°C	24%	Within Limits	Amit Joshi

Annexure-4: PPE Compliance Log

Date	Employee Name	Material Handled	PPE Used	Compliance Status	Verified By
14/03/2025	Ravi Kumar	Sodium	Gloves, Face Shield, Lab Coat	Compliant	Neha Verma
14/03/2025	Amit Joshi	Calcium Carbide	Gloves, Goggles, Respirator	Compliant	Priya Singh

Annexure-5: Material Handling Log

Date	Material Name	Batch Number	Handling Procedure	Handled By	Verified By
14/03/2025	Sodium	SOD-1234	Transferred using non-sparking tools in dry conditions	Ravi Kumar	Neha Verma
14/03/2025	Calcium Carbide	CCB-5678	Handled in moisture-free environment with full PPE	Amit Joshi	Priya Singh

Annexure-6: Spill Incident Log

Date	Material Name	Batch Number	Spill Description	Action Taken	Reported By
14/03/2025	Sodium	SOD-1234	Minor spill during transfer	Contained using dry sand, disposed in hazardous waste bin	Ravi Kumar
14/03/2025	Calcium Carbide	CCB-5678	Accidental exposure to humid air	Sealed immediately, moved to quarantine	Amit Joshi

Annexure-7: Emergency Response Log

Date	Incident Description	Immediate Response	Personnel Involved	Final Resolution	Verified By
14/03/2025	Fire due to accidental water exposure	Evacuated area, used Class D extinguisher	Neha Verma, Ravi Kumar	Fire contained, material disposed as hazardous waste	Priya Singh
14/03/2025	Sudden rise in humidity in storage area	Activated dehumidifiers, transferred sensitive materials	Amit Joshi	Humidity levels stabilized, no material damage reported	Neha Verma

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
14/03/2025	2.0	Updated storage and emergency response protocols	Alignment with updated GMP and safety guidelines	QA Head