Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
Temperature excursions during pharmaceutical distribution can compromise product quality and patient safety. This checklist ensures cold chain controls meet EU GDP Guidelines and WHO Technical Report Series No. 961 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Per Shipment / Monthly Cold Storage
- Estimated Time: 20-30 minutes
- Role: Logistics Quality Manager / Distribution Compliance Specialist
- Total Items: 31
- Compliance: EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01, WHO Technical Report Series No. 961 Annex 9 Model Guidance for Storage and Transport, USP <1079> Good Storage and Shipping Practices, FDA Guidance for Industry - Product-Specific Guidance for Temperature-Sensitive Products
Cold Storage Facility
Inspect cold storage area and equipment.
- Cold storage area temperature continuously monitored and within specification?
- Temperature alarm system functional with 24/7 response capability?
- Backup power or secondary cooling available for refrigeration units?
- No temperature excursions in current period?
- Temperature mapping qualification current for storage area?
Temperature Monitoring Devices
Verify monitoring device qualification and calibration.
- All temperature monitoring devices calibrated with current certificates?
- Temperature data loggers placed per mapping study locations?
- Continuous temperature logging with minimum 15-minute intervals?
- Temperature data reviewed and signed off regularly?
- Temperature records retained per GDP requirements (minimum 1 year)?
Shipping Packaging and Validation
Review shipping container and thermal packaging.
- Thermal shipping containers qualified for all lane temperature and duration requirements?
- Shipping validation performed for summer and winter seasonal extremes?
- Written packing SOPs followed with coolant charge and placement documented?
- Coolants (gel packs) pre-conditioned per qualification protocol before packing?
- Temperature logger included in each shipment?
Distribution Lane Qualification
Review distribution lane qualification.
- All distribution lanes (origin to destination) qualified?
- Carriers qualified with audit or GDP certification?
- Carrier temperature-controlled vehicles temperature mapped and validated?
- Handoff procedures between carrier and facility documented?
- Transit time within shipping container qualification duration?
Excursion Management
Review excursion handling procedures.
- Written excursion handling SOP with decision tree for product disposition?
- All temperature excursions investigated with root cause and CAPA?
- Stability data supporting product disposition decisions available?
- Excursions reported to manufacturer per quality agreement?
- Excursion trending performed to identify systemic issues?
GDP Documentation
Verify GDP documentation compliance.
- Responsible Person (RP) designated per EU GDP requirements?
- All GDP-required procedures documented and current?
- All personnel trained on GDP requirements and procedures?
- GDP self-inspections performed per schedule?
- Product complaint and recall procedures including temperature-related?
- Cold chain inspection report prepared?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- Pharmaceutical Incoming Material Sampling and Testing Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
- GxP Training Compliance and Competency Audit Checklist
- FDA Inspection Readiness Assessment Checklist
- Pharmaceutical Product Recall Readiness Checklist
- FDA GMP Inspection Readiness Audit Checklist
Related Supply Chain Checklists
- Pharmaceutical Supplier Qualification Audit Checklist - FREE Download
- Pharmaceutical Packaging Materials Audit and Inspection Checklist - FREE Download
- Pharmaceutical Incoming Material Sampling and Testing Checklist - FREE Download
Why Use This Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist?
This pharmaceutical cold chain and temperature-sensitive logistics inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for logistics quality manager / distribution compliance specialist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per shipment / monthly cold storage.
Ensures compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01, WHO Technical Report Series No. 961 Annex 9 Model Guidance for Storage and Transport, USP <1079> Good Storage and Shipping Practices, FDA Guidance for Industry - Product-Specific Guidance for Temperature-Sensitive Products. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist cover?
This checklist covers 31 inspection items across 6 sections: Cold Storage Facility, Temperature Monitoring Devices, Shipping Packaging and Validation, Distribution Lane Qualification, Excursion Management, GDP Documentation. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed per shipment / monthly cold storage. Each completion takes approximately 20-30 minutes.
Who should use this Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist?
This checklist is designed for Logistics Quality Manager / Distribution Compliance Specialist professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.