Inspections, Compliance, Enforcement, and Criminal Investigations

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

BACKGROUND

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.

POLICY:

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
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.