Standard Operating Procedure for Storage of Temperature-Sensitive Materials in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/006/2025
Supersedes	SOP/API/006/2022
Page No.	Page 1 of 11
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To describe the procedure for receiving, storing, monitoring, and handling temperature-sensitive raw materials such as APIs, excipients, and solvents that require specific temperature conditions to maintain their quality and stability in the API manufacturing warehouse.

2. Scope

This SOP applies to all temperature-sensitive materials received and stored in cold rooms, refrigerators, or temperature-controlled storage areas within the API manufacturing facility.

3. Responsibilities

• Warehouse Personnel: Store materials in designated temperature zones, record temperature readings, and maintain logs.
• QA Officer: Review temperature monitoring data and investigate deviations.
• Engineering/Maintenance Team: Maintain and calibrate temperature-controlled equipment.

4. Accountability

The Warehouse Manager is accountable for ensuring that temperature-sensitive materials are stored under prescribed conditions and monitored as per regulatory guidelines.

5. Procedure

5.1 Identification of Temperature-Sensitive Materials

1. During material receipt, verify storage conditions mentioned in the CoA, MSDS, or label.
2. Examples of storage requirements:
   • 2°C to 8°C – Refrigerated Storage
   • -20°C – Frozen Storage
   • 15°C to 25°C – Controlled Room Temperature
3. Label containers with “Temperature-Sensitive – Store at [Required Temp]” using color-coded tags.

5.2 Storage Equipment and Infrastructure

1. Use validated cold rooms, refrigerators, or deep freezers for storing such materials.
2. Each unit should be equipped with:
   • Digital temperature display
   • 24×7 temperature data logger
   • Alarm system for excursions
   • Back-up power supply
3. Do not overload storage units to ensure uniform temperature circulation.

5.3 Storage Process

1. Place materials in their respective designated shelves based on temperature category.
2. Maintain physical segregation between different materials.
3. Update the “Temperature-Sensitive Storage Log” (Annexure-1) for each batch stored.

5.4 Temperature Monitoring

1. Warehouse staff must record temperature twice daily (morning and evening).
2. Download and archive data from digital loggers weekly and review for excursions.
3. QA should verify and sign off the logs weekly.
4. If temperature excursion is noted:
   • Label material as “On Hold”
   • Inform QA and initiate deviation form
   • QA shall assess impact and decide on disposition

5.5 Calibration and Maintenance

1. Temperature measuring devices must be calibrated every 6 months or as per SOP.
2. Calibration certificates shall be attached to the “Calibration Log” (Annexure-2).
3. Preventive maintenance shall be conducted monthly and recorded.

5.6 Handling During Power Failure

1. Ensure storage units are connected to UPS or generator.
2. In case of extended outage:
   • Transfer materials to a validated backup storage
   • Document transfer in the “Emergency Transfer Log” (Annexure-3)

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• MSDS: Material Safety Data Sheet
• UPS: Uninterruptible Power Supply

7. Documents

1. Temperature-Sensitive Storage Log (Annexure-1)
2. Calibration Log (Annexure-2)
3. Emergency Transfer Log (Annexure-3)

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 961 Annex 9 – Storage and Transport of Time and Temperature-Sensitive Products
• 21 CFR Part 211.142 – Warehousing procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rajesh Kumar	Sunita Reddy	Manoj Verma
Designation	Warehouse Officer	QA Executive	QA Manager
Department	API Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Temperature-Sensitive Storage Log

Date	Material	Batch No.	Storage Unit	Temp. Recorded	Initials
13/04/2025	Enzyme A	ENZ202504	Refrigerator 01	5.2°C	RK

Annexure-2: Calibration Log

Date	Device ID	Calibrated By	Next Due	Certificate No.
01/04/2025	THERMO-02	Caltech Pvt. Ltd.	01/10/2025	CAL/2025/042

Annexure-3: Emergency Transfer Log

Date	Material	From	To	Reason	Authorized By
13/04/2025	Enzyme A	Refrigerator 01	Backup Cold Room	Power Failure	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial SOP	New Process	QA Head
13/04/2025	2.0	Added Calibration & Emergency Transfer Log	GMP Upgrade	QA Head