[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: 21CFR606.140]

[Page 51]
 
                        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 H--Laboratory Controls
 
Sec. 606.140  Laboratory controls.


    Laboratory control procedures shall include:
    (a) The establishment of scientifically sound and appropriate 
specifications, standards and test procedures to assure that blood and 
blood components are safe, pure, potent and effective.
    (b) Adequate provisions for monitoring the reliability, accuracy, 
precision and performance of laboratory test procedures and instruments.
    (c) Adequate identification and handling of all test samples so that 
they are accurately related to the specific unit of product being 
tested, or to its donor, or to the specific recipient, where applicable.