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Standard Operating Procedure for IP Storage, Temperature Control and Excursion Management

Purpose

The purpose of this SOP is to establish standardized procedures for the storage, temperature monitoring, and excursion management of investigational products (IP) at clinical trial sites. Proper storage safeguards product integrity, ensures participant safety, and maintains compliance with regulatory requirements.

Scope

This SOP applies to all clinical trial staff responsible for handling IP storage, including investigators, pharmacists, study coordinators, and CRO staff. It covers controlled room temperature storage, refrigerated and frozen storage, temperature monitoring, and excursion reporting.

Responsibilities

• Principal Investigator (PI): Ensures IP is stored in accordance with protocol and regulatory requirements.
• Pharmacist/Authorized Designee: Maintains IP storage conditions, temperature logs, and manages excursions.
• Study Coordinator: Files storage and excursion records in ISF and TMF.
• Sponsor/CRO: Provides guidance on excursion management and reviews storage records during monitoring visits.
• Quality Assurance Officer: Audits IP storage compliance during inspections.

Accountability

The PI is accountable for ensuring proper storage of IP at all times. Sponsors are accountable for oversight of IP storage practices across all participating sites.

Procedure

1. Storage Requirements
Store IP in secure, access-controlled areas with restricted entry.
Follow manufacturer’s storage requirements (e.g., 2–8°C refrigerated, -20°C frozen, 15–25°C controlled room temperature).
Maintain segregation of different batches and products.

2. Temperature Monitoring
Use calibrated, validated digital thermometers or data loggers.
Record temperatures twice daily (morning and evening) in Temperature Log (Annexure-1).
Retain calibration certificates for equipment.

3. Excursion Management
If temperature falls outside the acceptable range, immediately quarantine affected IP.
Notify PI, sponsor, and QA.
Complete Temperature Excursion Report (Annexure-2).
Await sponsor instructions before releasing product for use.

4. Documentation
Maintain IP Storage Log, Temperature Logs, and Excursion Reports in ISF and TMF.
File corrective actions and sponsor correspondence with storage records.

5. Security and Access
Restrict access to pharmacy or storage area to authorized personnel only.
Maintain access control records.

6. Archiving
Archive all IP storage and excursion records for at least 5 years post-trial or as per national regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IP: Investigational Product
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. Temperature Monitoring Log (Annexure-1)
2. Temperature Excursion Report (Annexure-2)
3. IP Storage Access Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trials Guidance on IP Handling
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Good Storage and Distribution Practices

Version: 1.0

Approval Section

Annexures

Annexure-1: Temperature Monitoring Log

Annexure-2: Temperature Excursion Report

Annexure-3: IP Storage Access Log

Revision History

For more SOPs visit: Pharma SOP