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
- Receive temperature-sensitive pharmaceutical products in designated receiving areas.
- Verify shipment integrity and temperature monitoring devices.
- Transfer products to appropriate cold storage conditions immediately.
4.2 Temperature Monitoring
- Monitor and record temperature conditions continuously during storage and transportation.
- Address temperature excursions promptly as per predefined procedures.
4.3 Cold Chain Distribution
- Package temperature-sensitive products with adequate cold packs or insulation materials.
- Ensure appropriate transportation vehicles and conditions.
4.4 Documentation and Record Keeping
- Maintain accurate records of temperature monitoring, storage conditions, and transportation.
- 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