Inspections, Compliance, Enforcement, and Criminal Investigations

CPG Sec. 231.110- Quality Control Testing of *Platelets* [ ] and Cryoprecipitated Antihemophilic Factor [ ]


The *Center for Biologics Evaluation and Research (CBER)* has re-evaluated the requirements of 21 CFR 640.25(b) and 640.56(a). These sections state that each month 4 units of *Platelets* [] and Cryoprecipitated Antihemophilic Factor [] prepared from different donors, shall be quality control tested. This has previously been interpreted to mean every month, even when *Platelets* [] and Cryoprecipitated Antihemophilic Factor [] are not prepared for clinical use by the blood bank. *However, CBER* believes that quality control testing of the product need be performed only in the months that the product is prepared for use.


Quality control testing and assay, at the end of the dating period, for *platelets* [] need be performed only in those months in which *platelets* [] are prepared for use. Similarly, Cryoprecipitated Antihemophilic Factor [] quality control testing need only be performed during months in which this product is prepared for use.

*Material between asterisks is new or revised*

[] Indicates material has been deleted

Issued: 12/26/78 as 7134.17
Revised: 10/1/80, 4/1/ 82, 3/95

Page Last Updated: 03/20/2015
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