[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: 21CFR606.20]

[Page 43-44]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                  Subpart B--Organization and Personnel
 
Sec. 606.20  Personnel.


    (a) [Reserved]
    (b) The personnel responsible for the collection, processing, 
compatibility testing, storage or distribution of blood or blood 
components shall be adequate in number, educational background, training 
and experience, including professional training as necessary, or 
combination thereof, to assure competent performance of their assigned 
functions, and to ensure that the final product has the safety, purity, 
potency, identity and effectiveness it purports or is represented to 
possess. All personnel shall have capabilities commensurate with their 
assigned functions, a thorough understanding of the procedures or 
control operations they perform, the necessary training or experience, 
and adequate information

[[Page 44]]

concerning the application of pertinent provisions of this part to their 
respective functions.
    (c) Persons whose presence can adversely affect the safety and 
purity of the products shall be excluded from areas where the 
collection, processing, compatibility testing, storage or distribution 
of blood or blood components is conducted.

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997]