Table 2.

Stakeholders and Quality Assurance Throughout the Cold Chain.

	Manufacturer	Distributor/wholesaler	Pharmacy/hospital	People with diabetes
Guidelines	Good Distribution Guidelines by WHO, European Commission, US Pharmacopeia, etc.			Limited, inconsistent information in guidelines by health organizations
			National law for pharmacies/hospitals
Other quality systems	Quality system by manufacturer Contracts with distributors		Quality system by institution
Available information	Knowledge of stability data	Package leaflet, might know stability data	Package leaflet, professional training	Package leaflet, education from HCPs, product website
Quality assurance measures	- Liability of manufacturer, responsibility to recall products - Risk assessment based on recorded temperature data - Audits, quality control - Training of staff - Use of validated materials (medical refrigerators, tested shipping boxes, refrigerated transporters, etc.) - Temperature monitoring - Documentation			- No quality control - No risk assessment possible - Suboptimal storage in home refrigerator - Use of cool bags

Abbreviation: HCPs, health care professionals.