and supplier documentation.

Label all chemicals clearly with hazard symbols and storage instructions.

Document identification details in the Hazardous Chemical Identification Log (Annexure-1).

Classification of Chemicals:

• Classify chemicals as flammable, corrosive, toxic, or reactive based on MSDS data.
• Segregate incompatible chemicals to prevent dangerous reactions.
• Document classifications in the Chemical Classification Log (Annexure-2).

5.2 Storage Requirements for Hazardous Chemicals

1. Explosion-Proof Storage:
   • Store flammable chemicals in explosion-proof cabinets equipped with proper ventilation and grounding.
   • Ensure corrosive substances are stored in corrosion-resistant containers and cabinets.
   • Document storage details in the Hazardous Chemical Storage Log (Annexure-3).
2. Labeling and Signage:
   • Clearly label storage areas with appropriate hazard signs and emergency contact information.
   • Ensure containers have intact and legible labels at all times.

5.3 Handling Procedures for Hazardous Chemicals

1. Personal Protective Equipment (PPE):
   • Wear appropriate PPE, including gloves, goggles, face shields, and respirators when handling hazardous chemicals.
   • Document PPE issuance in the PPE Usage Log (Annexure-4).
2. Safe Handling Practices:
   • Handle chemicals in designated areas with proper ventilation systems, such as fume hoods.
   • Ensure all containers are sealed properly after use to prevent leaks and vapors.
   • Document handling activities in the Chemical Handling Log (Annexure-5).

5.4 Monitoring and Maintenance of Storage Areas

1. Regular Inspections:
   • Inspect storage areas weekly for signs of leaks, corrosion, or improper labeling.
   • Ensure emergency equipment (e.g., eyewash stations, fire extinguishers) is functional.
   • Document inspection results in the Storage Area Inspection Log (Annexure-6).
2. Maintenance Procedures:
   • Repair any damaged containers or storage cabinets immediately to prevent exposure risks.
   • Document maintenance activities in the Maintenance Log (Annexure-7).

5.5 Handling of Deviations and Spills

1. Deviation Detection:
   • Identify deviations such as leaks, temperature fluctuations, or improper storage conditions through regular monitoring.
   • Isolate affected chemicals immediately and report deviations to QA.
   • Document deviations in the Deviation Log (Annexure-8).
2. Spill Response Procedures:
   • In case of a spill, evacuate the area and use appropriate spill kits and protective equipment.
   • Ventilate the area and safely dispose of contaminated materials following hazardous waste protocols.
   • Document spill responses in the Spill Response Log (Annexure-9).

5.6 Periodic Review and Compliance Monitoring

1. Warehouse Inspections:
   • Conduct routine inspections of hazardous chemical storage areas to ensure compliance with safety protocols.
   • Document inspection results in the Warehouse Inspection Log (Annexure-10).
2. QA Compliance Audits:
   • QA will conduct quarterly audits to ensure hazardous chemical storage complies with regulatory requirements.
   • Document audit findings in the Compliance Audit Log (Annexure-11).

6. Abbreviations

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

7. Documents

1. Hazardous Chemical Identification Log (Annexure-1)
2. Chemical Classification Log (Annexure-2)
3. Hazardous Chemical Storage Log (Annexure-3)
4. PPE Usage Log (Annexure-4)
5. Chemical Handling Log (Annexure-5)
6. Storage Area Inspection Log (Annexure-6)
7. Maintenance Log (Annexure-7)
8. Deviation Log (Annexure-8)
9. Spill Response Log (Annexure-9)
10. Warehouse Inspection Log (Annexure-10)
11. Compliance Audit Log (Annexure-11)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• NFPA 400 – Hazardous Materials Code
• WHO GMP Guidelines

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 Chemical Identification Log

Date	Chemical Name	Hazard Classification	Identified By
16/02/2025	Acetone	Flammable	Ravi Kumar

Annexure-2: Chemical Classification Log

Date	Chemical Name	Classification	Documented By
16/02/2025	Sulfuric Acid	Corrosive	Sunita Sharma

Annexure-3: Hazardous Chemical Storage Log

Date	Chemical Name	Storage Area	Stored By
16/02/2025	Acetone	Explosion-Proof Cabinet 1	Ravi Kumar

Annexure-4: PPE Usage Log

Date	Chemical Handled	PPE Used	Issued By
16/02/2025	Acetone	Gloves, Goggles, Face Shield	Anjali Mehta

Annexure-5: Chemical Handling Log

Date	Chemical Name	Handling Activity	Handled By
16/02/2025	Acetone	Transferred to QC Lab	Sunita Sharma

Annexure-6: Storage Area Inspection Log

Date	Area Inspected	Findings	Inspected By
16/02/2025	Hazardous Chemical Storage Room	No issues detected	Anjali Mehta

Annexure-7: Maintenance Log

Date	Area Maintained	Maintenance Activity	Performed By
15/02/2025	Explosion-Proof Cabinet 1	Replaced ventilation filter	Ravi Kumar

Annexure-8: Deviation Log

Date	Deviation	Action Taken	Reported By
15/02/2025	Corrosive label missing on sulfuric acid container	Reapplied label	Sunita Sharma

Annexure-9: Spill Response Log

Date	Chemical Spilled	Spill Size	Action Taken	Handled By
15/02/2025	Acetone	200 ml	Used spill kit, ventilated area	Ravi Kumar

Annexure-10: Warehouse Inspection Log

Date	Area Inspected	Findings	Corrective Actions	Inspected By
16/02/2025	Hazardous Storage Area	No deviations found	N/A	Anjali Mehta

Annexure-11: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
17/02/2025	Hazardous Chemical Storage Compliance Audit	Compliant	N/A	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
16/02/2025	2.0	Updated Storage Procedures for Regulatory Compliance	Regulatory Requirements	QA Head