APIs or flammable solvents, in dedicated areas with appropriate safety measures.

Document segregation practices in the Material Segregation Log (Annexure-1).

Use of Barriers and Signage:

• Install physical barriers (e.g., partitions, sealed containers) to prevent cross-contact between different materials.
• Clearly label storage areas and racks to indicate the type and status of stored materials.
• Document labeling and barrier use in the Storage Compliance Log (Annexure-2).

5.2 Environmental Controls

1. Airflow and Ventilation:
   • Ensure proper airflow patterns in the warehouse to prevent airborne contamination between storage zones.
   • Use HEPA filters and maintain positive pressure in clean areas, while negative pressure should be maintained in hazardous material zones.
   • Document airflow and ventilation checks in the Environmental Control Log (Annexure-3).
2. Temperature and Humidity Control:
   • Maintain temperature and humidity within specified ranges to prevent material degradation and contamination.
   • Monitor environmental conditions twice daily and document in the Temperature and Humidity Log (Annexure-4).

5.3 Handling Procedures to Prevent Cross-Contamination

1. Use of Dedicated Equipment:
   • Use dedicated tools and equipment (e.g., scoops, containers) for different raw materials to prevent cross-contact.
   • Clean and sanitize equipment thoroughly between uses if sharing is unavoidable.
   • Document equipment use and cleaning in the Equipment Handling Log (Annexure-5).
2. Personal Protective Equipment (PPE):
   • Ensure all personnel wear appropriate PPE, such as gloves, masks, and gowns, when handling raw materials.
   • Change PPE when switching between different material types to prevent cross-contamination.
   • Record PPE compliance in the PPE Monitoring Log (Annexure-6).

5.4 Cleaning and Sanitization

1. Routine Cleaning:
   • Clean storage racks, floors, and surrounding areas regularly using approved cleaning agents.
   • Ensure cleaning is performed after material spills or product changes.
   • Document cleaning activities in the Cleaning Log (Annexure-7).
2. Sanitization Procedures:
   • Sanitize high-touch surfaces and storage containers periodically to reduce microbial contamination risks.
   • Use validated sanitizers approved by QA.
   • Record sanitization activities in the Sanitization Log (Annexure-8).

5.5 Monitoring, Audits, and Corrective Actions

1. Daily Monitoring:
   • Warehouse personnel must perform daily checks for compliance with cross-contamination prevention practices.
   • Document findings in the Daily Monitoring Log (Annexure-9).
2. QA Audits:
   • QA will conduct monthly audits to verify compliance with this SOP.
   • Record audit findings in the QA Audit Log (Annexure-10).
3. Handling Deviations:
   • Report deviations, such as improper segregation or cross-contamination incidents, immediately to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-11).
4. Corrective Actions:
   • Investigate root causes of deviations and implement corrective measures like retraining staff or enhancing barriers.
   • Document corrective actions in the Corrective Action Log (Annexure-12).

6. Abbreviations

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

7. Documents

1. Material Segregation Log (Annexure-1)
2. Storage Compliance Log (Annexure-2)
3. Environmental Control Log (Annexure-3)
4. Temperature and Humidity Log (Annexure-4)
5. Equipment Handling Log (Annexure-5)
6. PPE Monitoring Log (Annexure-6)
7. Cleaning Log (Annexure-7)
8. Sanitization Log (Annexure-8)
9. Daily Monitoring Log (Annexure-9)
10. QA Audit Log (Annexure-10)
11. Deviation Log (Annexure-11)
12. Corrective Action Log (Annexure-12)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Standards for Hazardous Materials Handling

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Segregation Log

Date	Material Name	Status	Storage Area	Performed By
23/02/2025	API A	Quarantined	Quarantine Zone A	Ravi Kumar

Annexure-2: Storage Compliance Log

Date	Material Name	Storage Area	Barriers/Labeling Used	Checked By
23/02/2025	Solvent B	Hazardous Storage Area	Physical Barriers Installed	Sunita Sharma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
23/02/2025	2.0	Updated Cross-Contamination Prevention Procedures	Regulatory Compliance	QA Head