The introduction to and inspiration from FDA Guidance: alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical / 中国输血杂志

ABSTRACT

U.S. Food and Drug Administration recently issued a guidance on alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical. It was allowed to use platelets stored at 1 ℃ to 6 ℃, with a storage period of up to 14 days from the date of collection.The validation and quality monitoring of platelet manufacture retained pH items testing at the end of the storage, and platelet count and actual plasma volume testing items were not required. The guidance provided the recommendations and considerations for the manufacture, labeling, storage, transportation, bacterial contamination control, process validation, and quality monitoring sampling of cold-stored platelets, as well as the further research needs for its efficacy, particularly when conventional platelets are available and their use is practical. The scientific and regulatory considerations on cold-stored platelets in the guidance would be informative and instructive to the development of blood regulation and standards related with urgent transfusion in China.