Uniform Blood and Blood Component Container Labels

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

In June 2014, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Background for the publication was the request of the International Council for Commonality in Blood Banking Automation (ICCBBA) to replace the Version 2.0.0 Standard currently in use for container labels for blood and blood components by the revised Version 3.0.0 Standard. ICCBBA has submitted this revised version in 2013.

The Version 3.0.0 Standard is considerably reorganised and expanded from the Version 2.0.0 Standard.  However, there are only limited substantive revisions when compared to the Version 2.0.0 Standard.  Specific revisions in the Version 3.0.0 Standard when compared to the Version 2.0.0 Standard include:

• Providing for the abbreviation of certain words to reduce the amount of printing space needed on a label;
• Providing that the Donation Identification Number be printed such that all characters are the same font, colour, and print size;
• Providing that blood products collected from autologous donors that are not eligible for crossover be encoded with an “X” or a “1” in the product code;
• Specifying that the term “OPEN SYSTEM” be printed on the label if the product is manufactured in an open system;
• Including instructions for labeling products containing platelet additive solutions; and
• Clarifying when the name and location of a modifying facility (if different from that of the collection facility) needs to be printed on the label.

Furthermore, note that many more examples of labels and text are included in Version 3.0.0 Standard.

Please also read the complete document for more detailed information.