[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.25]

[Page 90-91]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                          Subpart C--Platelets
 
Sec. 640.25  General requirements.

    (a) Storage. Immediately after resuspension, Platelets shall be 
placed in storage at the selected temperature range. If stored at 20 to 
24  deg.C, a continuous gentle agitation of the platelet concentrate 
shall be maintained throughout the storage period. Agitation is optional 
if stored at a temperature between 1 and 6  deg.C.
    (b) Quality control testing. Each month four units prepared from 
different donors shall be tested at the end of the storage period as 
follows:
    (1) Platelet count.
    (2) pH of not less than 6.0 measured at the storage temperature of 
the unit.
    (3) Measurement of actual plasma volume.
    (4) If the results of the quality control testing indicate that the 
product does not meet the prescribed requirements, immediate corrective 
action shall be taken and a record maintained of such action.
    (c) Manufacturing responsibility. All manufacturing of Platelets 
shall be performed at the same licensed establishment, except that the 
quality control testing under paragraph (b) of this section may be 
performed by a clinical laboratory which meets the standards of the 
Clinical Laboratories Improvement Amendments of 1988 (CLIA) (42 U.S.C. 
263a) and is qualified to perform platelet counts. Such arrangements 
must be approved by the Director, Center for Biologics Evaluation and 
Research, Food and Drug Administration. Such testing shall not be 
considered as divided manufacturing, as described in Sec. 610.63 of this 
chapter, provided the following conditions are met:
    (1) The results of each test are received within 10 days of the 
preparation of the platelet concentrate, and are maintained by the 
establishment licensed for Platelets so that they may

[[Page 91]]

be reviewed by an authorized representative of the Food and Drug 
Administration.
    (2) The licensed Platelets manufacturer has obtained a written 
agreement that the testing laboratory will permit an authorized 
representative of the Food and Drug Administration to inspect its 
testing procedures and facilities during reasonable business hours.
    (3) The testing laboratory will participate in any proficiency 
testing programs undertaken by the Center for Biologics Evaluation and 
Research, Food and Drug Administration.

[40 FR 4304, Jan. 29, 1975, as amended at 47 FR 49021, Oct. 29, 1982; 49 
FR 23834, June 8, 1984; 50 FR 4139, Jan. 29, 1985; 55 FR 11013, Mar. 26, 
1990; 66 FR 1836, Jan. 10, 2001]