Ensure that safety protocols are followed during the handling of strong-smelling or potentially hazardous materials.

4. Accountability

The Warehouse Manager is accountable for ensuring that odorous materials are stored in designated areas with appropriate controls. The QA Manager is responsible for verifying compliance with this SOP through regular inspections.

5. Procedure

5.1 Identification and Classification of Odorous Materials

1. Material Identification:
   • All materials with strong or volatile odors must be identified upon receipt.
   • Examples include essential oils (e.g., eucalyptus oil), flavoring agents (e.g., menthol), solvents (e.g., acetone), and specific chemicals (e.g., ammonia).
   • Document odorous materials in the Odorous Material Identification Log (Annexure-1).
2. Classification of Odor Intensity:
   • Classify materials into three categories:
     • High-Intensity: Strong-smelling solvents and chemicals.
     • Medium-Intensity: Essential oils and flavoring agents.
     • Low-Intensity: Mild-smelling compounds that still require segregation.
   • Record classification in the Odorous Material Classification Log (Annexure-2).

5.2 Storage and Segregation Procedures

1. Dedicated Storage Areas:
   • Store odorous materials in dedicated, well-ventilated storage rooms separate from non-odorous raw materials.
   • Ensure storage areas are equipped with proper ventilation systems to prevent odor accumulation.
   • Document storage locations in the Odorous Material Storage Log (Annexure-3).
2. Packaging and Containment:
   • Ensure odorous materials are stored in tightly sealed, odor-proof containers.
   • Use secondary containment when necessary to prevent leaks or vapor release.
   • Document packaging status in the Odorous Material Packaging Log (Annexure-4).

5.3 Handling Procedures for Odorous Materials

1. Personal Protective Equipment (PPE):
   • Warehouse personnel must wear appropriate PPE, including gloves, masks, and goggles when handling odorous materials.
   • Document PPE usage in the PPE Compliance Log (Annexure-5).
2. Minimizing Exposure:
   • Handle odorous materials in designated handling areas to limit exposure to other warehouse zones.
   • Minimize the time that containers remain open during material handling.
   • Document handling activities in the Odorous Material Handling Log (Annexure-6).

5.4 Monitoring and Inspection

1. Routine Inspections:
   • Conduct weekly inspections of dedicated storage areas to check for leaks, spills, or improper sealing of containers.
   • Document inspection findings in the Odorous Material Inspection Log (Annexure-7).
2. Cross-Contamination Risk Assessment:
   • QA must perform monthly risk assessments to ensure no cross-contamination occurs with non-odorous materials.
   • Document assessments in the Odor Cross-Contamination Risk Log (Annexure-8).

6. Abbreviations

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

7. Documents

1. Odorous Material Identification Log (Annexure-1)
2. Odorous Material Classification Log (Annexure-2)
3. Odorous Material Storage Log (Annexure-3)
4. Odorous Material Packaging Log (Annexure-4)
5. PPE Compliance Log (Annexure-5)
6. Odorous Material Handling Log (Annexure-6)
7. Odorous Material Inspection Log (Annexure-7)
8. Odor Cross-Contamination Risk Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• OSHA Guidelines for Handling Hazardous Chemicals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Odorous Material Identification Log

Date	Material Name	Batch Number	Odor Intensity	Identified By
25/03/2025	Eucalyptus Oil	EO-1234	High	Ravi Kumar
25/03/2025	Acetone	AC-5678	High	Neha Verma

Annexure-2: Odorous Material Classification Log

Date	Material Name	Classification	Classified By
25/03/2025	Menthol Crystals	Medium-Intensity	Amit Joshi
25/03/2025	Ammonia Solution	High-Intensity	Priya Singh

Annexure-3: Odorous Material Storage Log

Date	Material Name	Storage Location	Storage Condition	Stored By
25/03/2025	Eucalyptus Oil	Dedicated Storage Room A	Sealed Container, Ventilated Room	Ravi Kumar
25/03/2025	Acetone	Hazardous Storage Area B	Sealed Drum, Fireproof Cabinet	Neha Verma

Annexure-4: Odorous Material Packaging Log

Date	Material Name	Packaging Type	Packaging Status	Packed By
25/03/2025	Menthol Crystals	Double-Layered Plastic Bags	Sealed and Odor-Proof	Amit Joshi
25/03/2025	Ammonia Solution	Sealed Glass Bottle	Secure, No Leakage	Priya Singh

Annexure-5: PPE Compliance Log

Date	Employee Name	PPE Used	Compliance Status	Verified By
25/03/2025	Ravi Kumar	Gloves, Mask, Goggles	Compliant	Neha Verma
25/03/2025	Priya Singh	Gloves, Mask	Compliant	Amit Joshi

Annexure-6: Odorous Material Handling Log

Date	Material Name	Handling Activity	Duration	Handled By
25/03/2025	Eucalyptus Oil	Transferred to Storage	10 Minutes	Ravi Kumar
25/03/2025	Acetone	Packaging and Labeling	15 Minutes	Neha Verma

Annexure-7: Odorous Material Inspection Log

Date	Storage Area	Inspection Findings	Corrective Action Required	Inspected By
25/03/2025	Dedicated Storage Room A	Proper Ventilation, No Odor Leak	None	Amit Joshi
25/03/2025	Hazardous Storage Area B	Minor Odor Detected	Seal Verification Required	Priya Singh

Annexure-8: Odor Cross-Contamination Risk Log

Date	Storage Area	Risk Identified	Mitigation Measures	Verified By
25/03/2025	Room A	Odor Migration Risk	Enhanced Ventilation Installed	Ravi Kumar
25/03/2025	Room B	Potential Contamination of Adjacent Materials	Physical Barrier Installed	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
25/03/2025	2.0	Added Cross-Contamination Risk Assessment	Enhance Safety and Compliance	QA Head