Transportation hazards affect drug product quality and efficacy.
You have to understand their impact. A range of environmental and operational conditions can influence drug product integrity during the transport process from point-of-manufacturer to point-of-distribution and finally to the patient at point-of-use:
• Exposure to extreme weather such as heatwaves, rain, or snow
• Packaging degradation
• Courier mishandling
• Import / export requirement delays
• Transit time and transit storage conditions
Regulatory scrutiny to ensure patient safety for all drug products for a global supply chain process requires a robust validation master plan to show that stress during transport does not impact drug product quality, reduce shelf life, or impacts patients’ safety. EMEA and FDA required elements for cold chain validation master plan:
• Packaging qualification
• Drug product characterization
• Transport validation
• Validation summary report
All these elements have to be fully integrated and well documented in your quality system prior to regulatory submission. We expect the scrutiny on the cold chain that has challenged many new biopharmaceuticals – including immunotherapies and biosimilars – to continue to delay and frustrate the submission process unless the manufacturer is properly prepared. The regulators are better versed on the potential dangers and have seen best practices in cold chain for years.