[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.1]

[Page 66]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                     Subpart A_Release Requirements
 
Sec.  610.1  Tests prior to release required for each lot.


    No lot of any licensed product shall be released by the manufacturer 
prior to the completion of tests for conformity with standards 
applicable to such product. Each applicable test shall be made on each 
lot after completion of all processes of manufacture which may affect 
compliance with the standard to which the test applies. The results of 
all tests performed shall be considered in determining whether or not 
the test results meet the test objective, except that a test result may 
be disregarded when it is established that the test is invalid due to 
causes unrelated to the product.