that materials are used in the correct order (FIFO method) and that materials are not used beyond their expiry date or shelf life.

4. Accountability

The Warehouse Manager is accountable for ensuring that this SOP is followed during the storage of dispensed materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Storage Area Setup

1. Dispensed materials must be stored in designated storage areas that are clean, dry, and free from contamination. The storage areas should be organized to minimize the risk of cross-contamination.
2. The storage area should be equipped with proper shelving, temperature control systems, and sufficient space to segregate materials by type, batch number, and material compatibility.
3. Ensure that the storage area is secured, with access limited to authorized personnel only. A sign-in/out system should be implemented to track personnel accessing the area.

5.2. Temperature and Environmental Control

1. Materials that require temperature control must be stored in temperature-controlled areas, such as refrigerators, freezers, or climate-controlled rooms. The temperature of the storage area should be monitored regularly, and deviations should be reported immediately.
2. If materials require specific environmental conditions (e.g., humidity control), the relevant equipment must be used to maintain these conditions, and regular checks should be performed.
3. Temperature and environmental monitoring logs should be maintained, and discrepancies should be recorded and addressed promptly.

5.3. Labeling and Segregation

1. All dispensed materials must be labeled with the relevant information, including material name, batch number, quantity, expiry date, and any special handling or storage instructions.
2. Materials must be segregated according to their specific storage requirements, such as temperature-sensitive, hazardous, or non-hazardous materials. Incompatible materials should be stored separately to avoid cross-contamination.
3. Materials that are nearing expiry should be clearly marked and used first, following the First-In, First-Out (FIFO) method.

5.4. Access and Security

1. The storage areas should be locked or otherwise secured to prevent unauthorized access to the materials. Only authorized personnel should be allowed to access the storage areas.
2. A detailed record of all personnel accessing the storage area should be kept in the Access Log, including the time of entry and the materials handled.

5.5. Regular Inspections

1. Regular inspections should be carried out to ensure that dispensed materials are stored correctly, the storage area is clean, and the conditions are maintained according to the specifications.
2. Any discrepancies or issues discovered during inspections should be addressed immediately. The inspection results should be documented in the Storage Inspection Log.

5.6. Handling of Expired or Damaged Materials

1. Any dispensed materials that are expired, damaged, or deemed unusable should be segregated and removed from the storage area.
2. The materials should be documented in the Material Disposal Log and disposed of according to the appropriate disposal procedure.

5.7. Corrective and Preventive Actions (CAPA)

1. In case of any discrepancies in the storage conditions or practices, corrective actions must be initiated. This may involve retraining personnel, adjusting procedures, or reviewing the storage area layout.
2. Preventive actions should be implemented to ensure that similar issues do not recur, such as regular staff training and equipment calibration.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• FIFO: First-In, First-Out
• CAPA: Corrective and Preventive Actions

7. Documents

1. Material Storage Log (Annexure-1)
2. Temperature Monitoring Log (Annexure-2)
3. Access Log (Annexure-3)
4. Storage Inspection Log (Annexure-4)
5. Material Disposal Log (Annexure-5)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

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 Storage Log

Material Name	Batch No.	Storage Date	Storage Conditions	Operator
Example Material	12345	06/02/2025	Room Temp, Dry	Ravi Kumar

Annexure-2: Temperature Monitoring Log

Storage Area	Temperature	Monitoring Date	Monitored By	Remarks
Freezer 1	-18°C	06/02/2025	Rajesh Patel	Pass

Annexure-3: Access Log

Personnel Name	Access Date	Time In	Time Out	Materials Handled
Ravi Kumar	06/02/2025	08:00	09:00	Example Material

Annexure-4: Storage Inspection Log

Inspection Date	Inspector Name	Storage Conditions	Remarks
06/02/2025	Rajesh Patel	Temperature-controlled	Pass

Annexure-5: Material Disposal Log

Material Name	Batch No.	Quantity Disposed	Disposal Date	Disposed By
Example Material	12345	10 kg	06/02/2025	Ravi Kumar

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated storage procedures and added inspection requirements	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures