Segregation:

• Segregate raw materials based on type (API, excipients, solvents), hazard classification (flammable, corrosive), and storage conditions (temperature-sensitive, light-sensitive).
• Document segregation details in the Material Segregation Log (Annexure-1).

FIFO/FEFO Implementation:

• Implement First-In-First-Out (FIFO) and First-Expiry-First-Out (FEFO) principles to manage inventory and prevent material degradation.
• Track FIFO/FEFO compliance in the FIFO/FEFO Compliance Log (Annexure-2).

5.2 Storage Conditions

1. Temperature and Humidity Control:
   • Maintain specified temperature and humidity conditions as per material requirements. Use calibrated equipment for monitoring.
   • Log readings in the Environmental Monitoring Log (Annexure-3).
2. Storage Equipment and Labeling:
   • Ensure storage racks, shelves, and containers are clean, labeled, and maintained. Use color-coded labels to indicate material status (approved, quarantined, rejected).
   • Document equipment status and labeling in the Storage Equipment and Labeling Log (Annexure-4).

5.3 Handling Procedures to Prevent Contamination

1. Proper Handling Techniques:
   • Ensure materials are handled with clean, sanitized equipment. Use personal protective equipment (PPE) when handling sensitive or hazardous materials.
   • Document handling procedures in the Material Handling Log (Annexure-5).
2. Cross-Contamination Prevention:
   • Use dedicated tools and storage areas for different material categories to prevent cross-contamination. Maintain a clear separation between APIs, excipients, and solvents.
   • Track cross-contamination control measures in the Cross-Contamination Control Log (Annexure-6).

5.4 Inspection and Compliance

1. Routine Inspections:
   • Conduct weekly inspections of storage areas to verify compliance with storage order protocols.
   • Record inspection results in the Storage Inspection Log (Annexure-7).
2. Audit and Corrective Actions:
   • Perform monthly audits to identify non-conformances and initiate corrective actions as needed.
   • Document audit findings in the Audit and Corrective Action Log (Annexure-8).

5.5 Training and Non-Conformance Handling

1. Employee Training:
   • Provide periodic training to warehouse staff on correct storage order and contamination prevention protocols.
   • Record training sessions in the Storage Order Training Log (Annexure-9).
2. Non-Conformance Handling:
   • Document any deviations from storage protocols in the non-conformance log and implement corrective actions.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• FIFO: First-In-First-Out
• FEFO: First-Expiry-First-Out

7. Documents

1. Material Segregation Log (Annexure-1)
2. FIFO/FEFO Compliance Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. Storage Equipment and Labeling Log (Annexure-4)
5. Material Handling Log (Annexure-5)
6. Cross-Contamination Control Log (Annexure-6)
7. Storage Inspection Log (Annexure-7)
8. Audit and Corrective Action Log (Annexure-8)
9. Storage Order Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Storage Practices for Pharmaceuticals
• FDA Guidance on Warehouse Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Material Segregation Log

Date	Material Name	Category (API/Excipient/Solvent)	Storage Area	Segregated By
11/04/2025	API X	API	Controlled Storage Area	Ravi Kumar

Annexure-2: FIFO/FEFO Compliance Log

Date	Material Name	Batch Number	Expiry Date	FIFO/FEFO Status	Checked By
11/04/2025	API X	Batch 12345	30/06/2025	Compliant	Neha Verma

Annexure-3: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Checked By
11/04/2025	Cold Storage	5°C	55%	Amit Joshi

Annexure-4: Storage Equipment and Labeling Log

Date	Equipment Type	Status	Labeling Status	Inspected By
11/04/2025	Shelf A1	Good	Properly Labeled	Priya Singh

Annexure-5: Material Handling Log

Date	Material Name	Handled By	PPE Used	Remarks
11/04/2025	Excipient Y	Ajay Sharma	Gloves, Mask	Properly Handled

Annexure-6: Cross-Contamination Control Log

Date	Material Name	Cross-Contamination Risk	Control Measures	Verified By
11/04/2025	API X	High	Dedicated Equipment	Kiran Patel

Annexure-7: Storage Inspection Log

Date	Storage Area	Inspector Name	Findings	Remarks
11/04/2025	Cold Storage	QA Supervisor	Compliant	No Issues Found

Annexure-8: Audit and Corrective Action Log

Date	Audit Area	Audit Findings	Corrective Actions	Completed By
11/04/2025	Shelf A1	Label Missing	Label Replaced	QA Manager

Annexure-9: Storage Order Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
11/04/2025	Sanjay Mehta	Storage Order Compliance	QA Manager	Completed Successfully

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
11/04/2025	2.0	Updated storage handling protocols and added contamination prevention measures.	Regulatory Update	QA Head