Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance) (c. 62)

ANNEX Quality system standards and specifications

7. STORAGE AND DISTRIBUTION

1. The quality system of the blood establishment shall ensure that, for blood and blood components intended for the manufacture of medicinal products, the storage and distribution requirements shall comply with Directive 2003/94/EC.

2. Procedures for storage and distribution shall be validated to ensure blood and blood component quality during the entire storage period and to exclude mix-ups of blood components. All transportation and storage actions, including receipt and distribution, shall be defined by written procedures and specifications.

3. Autologous blood and blood components as well as blood components collected and prepared for specific purposes shall be stored separately.

4. Appropriate records of inventory and distribution shall be kept.

5. Packaging shall maintain the integrity and storage temperature of blood or blood components during distribution and transportation.

6. Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all quality requirements and procedures laid down by the blood establishment to ensure blood component integrity are fulfilled.