List of the main “Cold Chain” principles that should be used in Delivery Contract of temperature-unstable immune-biological medications (hereinafter referred to as medications).
1. The Delivery Contract is negotiated between the Supplier and the Client directly.
2. If the Supplier is not the medication’s Manufacturer, but authorized Company it is required to attach to the Contract the Manufacturer letter of commitment. This letter focuses on if the Client has documented violations of supply (including violations of special temperature ranges), Manufacturer engages to supply the new lot by the time fixed in Contract.
3. The selection of thermo-containers leaves to Supplier choice.
4. On application of the cooling elements (icepacks) or other frozen means, the temperature control should be on the bottom and under the cover of the each container.
5. The temperature ranges during storage and transportation are controlled with the documentary monitoring instruments recommended for use in health care practice by National Ministry of Health on the Client’s territory.
6. The Client’s rights:
• To take part in medications sampling (manufactured for his order), to send it in special laboratory of Standardization and Quality Control;
• A right to control the medications temperature modes from the moment of the medications delivery to Supplier’s (Manufacturer’s) storage till the moment of its shipment to the Client;
• A right to control the medications temperature modes during transportation;
• A right to refuse acceptance of the medications with the temperature modes violations;
• A right to get the compensation for losses regarding the out-of-sequence delivery and violations in immunizations schedule.