10.1 The Quality System of the blood establishment should ensure that, for blood and blood components intended for the manufacture of medicinal products, the requirements for storage and distribution should comply with legal requirements.
10.2 Procedures for storage and distribution must be validated to ensure the quality of blood and blood components during the entire storage period, and to exclude mix-ups of blood components. All transportation and storage actions, including receipt and distribution, must be defined by written procedures and specifications.
10.3 Storage conditions must be controlled, monitored and checked. Appropriate alarms must be present and checked regularly; all checks must be recorded. Appropriate actions on alarms must be defined.
10.4 There should be a system to ensure stock rotation involving regular and frequent checks that the system is operating correctly. Blood and blood components beyond their expiry date or shelf-life should be separated from usable stock. Before distribution, blood components must be visually inspected.
10.5 Autologous blood and blood components, as well as blood components collected and prepared for specific purposes, must be stored separately. Appropriate records of inventory and distribution must be kept.
10.6 Records should be kept of the distribution of blood components between blood establishments, blood establishments and hospital blood banks and between hospital blood banks. These records should show the date of supply, unique component identifier and name of the blood component, the quantity received or supplied, name and address of the supplier or consignee.
10.7 Packaging must maintain the integrity and storage temperature of blood and blood components during distribution and transportation.