to 8°C, frozen items, and controlled room temperature (CRT) materials.

3. Responsibilities

• Warehouse Personnel: Store materials at designated temperature zones and maintain temperature logs.
• Production Operators: Handle and use materials as per the prescribed temperature limits.
• QA Personnel: Monitor compliance and review deviations and excursions.
• Engineering: Ensure temperature-controlled equipment functions correctly.

4. Accountability

The Head of Production and QA is accountable for ensuring compliance with this SOP, training of staff, and resolution of deviations related to temperature-sensitive materials.

5. Procedure

5.1 Receipt of Temperature-Sensitive Materials

1. Receive temperature-sensitive materials with temperature indicators or data loggers.
2. Verify during receipt that the transport temperature was maintained.
3. If excursion is suspected, quarantine the batch and inform QA for evaluation.

5.2 Storage Requirements

1. Store materials in temperature-mapped storage areas:
   • Cold Room (2–8°C)
   • Freezer (-20°C)
   • CRT (15–25°C)
2. Label each container with “Temperature-Sensitive” and the required storage condition.
3. Use calibrated digital temperature sensors with alarm systems.

5.3 Material Transfer

1. Use validated cold boxes or portable refrigerators during material transfer to manufacturing areas.
2. Monitor transfer duration and environmental conditions using portable data loggers.

5.4 During Manufacturing

1. Ensure manufacturing room conditions are within acceptable temperature limits.
2. Use temperature-controlled equipment such as jacketed tanks and insulated transfer lines if required.
3. Record batch start and end time for temperature-sensitive steps.

5.5 Monitoring

1. Monitor all temperature-controlled areas continuously using automated systems.
2. Daily checks must be documented in the Temperature Monitoring Log (Annexure-1).

5.6 Handling Temperature Excursions

1. If any excursion is noted:
   • Segregate affected materials immediately.
   • Document in the Temperature Excursion Log (Annexure-2).
   • Conduct impact assessment with QA.

5.7 Documentation

1. All storage equipment calibration records must be maintained.
2. Include temperature verification in the Batch Manufacturing Record (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CRT: Controlled Room Temperature
• BMR: Batch Manufacturing Record

7. Documents

1. Temperature Monitoring Log – Annexure-1
2. Temperature Excursion Log – Annexure-2
3. Batch Manufacturing Record – Annexure-3

8. References

• WHO Guidelines on Good Storage Practices
• EU GMP Annex 1
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Temperature Monitoring Log

Date	Location	Min Temp (°C)	Max Temp (°C)	Checked By
23/06/2025	Cold Room	2.1	7.8	Rajesh Kumar

Annexure-2: Temperature Excursion Log

Date	Location	Observed Temp	Duration	Material ID	Action Taken
20/06/2025	CRT Store	29°C	1 hour	APX123	Under Evaluation

Annexure-3: BMR Temperature Verification Section

Batch No.	Start Temp (°C)	End Temp (°C)	Operator	QA Verified
B1256	7.5	7.3	Sunita Reddy	Yes

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial version	New SOP	QA Head
24/06/2025	2.0	Updated transfer and documentation protocols	Annual Review	QA Head