Standard Operating Procedure for Cold Chain Management

1) Purpose

The purpose of this SOP is to establish procedures for maintaining the integrity of temperature-sensitive pharmaceutical products throughout the cold chain distribution and storage process.

2) Scope

This SOP applies to all personnel involved in handling, storing, and transporting temperature-sensitive pharmaceutical products within the cold chain.

3) Responsibilities

3.1 Warehouse and Logistics Team

• Receive and inspect temperature-sensitive shipments.
• Store products in designated cold storage areas.

3.2 Quality Assurance (QA) Team

• Monitor temperature conditions during storage and transportation.
• Investigate and address temperature excursions.

4) Procedure

4.1 Receipt and Storage

1. Receive temperature-sensitive pharmaceutical products in designated receiving areas.
2. Verify shipment integrity and temperature monitoring devices.
3. Transfer products to appropriate cold storage conditions immediately.

4.2 Temperature Monitoring

1. Monitor and record temperature conditions continuously during storage and transportation.
2. Address temperature excursions promptly as per predefined procedures.

4.3 Cold Chain Distribution

1. Package temperature-sensitive products with adequate cold packs or insulation materials.
2. Ensure appropriate transportation vehicles and conditions.

4.4 Documentation and Record Keeping

1. Maintain accurate records of temperature monitoring, storage conditions, and transportation.
2. Document investigations and corrective actions for temperature excursions.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Temperature Monitoring Records
• Temperature Excursion Reports
• Cold Chain Distribution Logs

7) Reference, if any

WHO: Guidelines on the International Packaging and Shipping of Vaccines
ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV

8) SOP Version

Version 1.0