and resolve discrepancies.

4. Accountability

The Warehouse Manager is responsible for ensuring that temperature-sensitive materials are received and handled according to specified requirements. The QA Manager holds authority to approve or reject materials based on temperature integrity, while the Procurement Manager ensures supplier compliance with temperature specifications. The QC Manager evaluates material quality if deviations occur.

5. Procedure

5.1 Pre-Receipt Preparations

1. Supplier Requirements:
   • Procurement ensures that suppliers provide transportation and temperature data, including:
     • Temperature monitoring devices (e.g., data loggers).
     • Temperature conditions during storage and transit.
   • Suppliers must confirm that materials have been transported under specified conditions.
2. Warehouse Preparations:
   • Ensure availability of temperature-controlled storage areas (e.g., refrigerators, freezers).
   • Verify that temperature monitoring equipment is calibrated and functional.

5.2 Receipt of Temperature-Sensitive Materials

1. Initial Inspection:
   • Upon arrival, verify the condition of transportation containers and packaging for temperature-sensitive materials.
   • Ensure packaging is intact and tamper-evident seals are in place.
   • Document initial inspection findings in the Temperature-Sensitive Material Receipt Log (Annexure-1).
2. Temperature Verification:
   • Review temperature monitoring devices (e.g., data loggers) to ensure materials were transported within specified temperature ranges.
   • Record temperature data in the Temperature Compliance Log (Annexure-2).

5.3 Handling of Temperature-Sensitive Materials

1. Immediate Transfer to Storage:
   • Immediately transfer temperature-sensitive materials to the designated temperature-controlled storage area.
   • Ensure minimal exposure to ambient temperatures during transfer.
2. Storage Conditions:
   • Ensure materials are stored under specified conditions (e.g., 2-8°C, -20°C, or ambient controlled).
   • Monitor and record storage conditions regularly in the Storage Temperature Log (Annexure-3).

5.4 Handling Temperature Deviations

1. Identification of Deviations:
   • If temperature deviations are detected, immediately segregate materials and label them as “UNDER REVIEW.”
   • Document deviations in the Temperature Deviation Report (Annexure-4).
2. QA Review and Corrective Actions:
   • QA reviews temperature deviation reports and determines the impact on material integrity.
   • QC may be instructed to perform additional testing to assess material quality.
   • Final disposition is recorded in the Material Disposition Log (Annexure-5).

5.5 Supplier Communication and Resolution

1. Supplier Notification:
   • Procurement contacts the supplier regarding any temperature deviations or handling issues.
   • Request corrective actions, such as improved packaging, transportation methods, or material replacement.
2. Corrective Action Documentation:
   • Document supplier responses and corrective actions in the Corrective Action Log (Annexure-6).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Temperature-Sensitive Material Receipt Log (Annexure-1)
2. Temperature Compliance Log (Annexure-2)
3. Storage Temperature Log (Annexure-3)
4. Temperature Deviation Report (Annexure-4)
5. Material Disposition Log (Annexure-5)
6. Corrective Action Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Temperature-Sensitive Material Receipt Log

Date	Material Name	Batch Number	Required Temperature (°C)	Received Temperature (°C)	Packaging Condition	Verified By	Remarks
01/02/2025	API-X	X-2025-001	2-8°C	4°C	Intact	John Doe	Compliant
01/02/2025	Excipient-Y	Y-2025-002	15-25°C	30°C	Intact	Jane Smith	Temperature Deviation Noted

Annexure-2: Temperature Compliance Log

Date	Material Name	Batch Number	Transport Temperature Data	Specified Range	Verified By	Remarks
01/02/2025	API-X	X-2025-001	Maintained 4°C	2-8°C	John Doe	Compliant

Annexure-3: Storage Temperature Log

Date	Material Name	Batch Number	Required Storage Temp (°C)	Recorded Temp (°C)	Checked By
01/02/2025	API-X	X-2025-001	2-8°C	5°C	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Added Procedures for Handling Temperature Deviations	Standardization	QA Head