[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.51]

[Page 129-130]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
                      Subpart F_Anti-Human Globulin
 
Sec. 660.51  Processing.

    (a) Processing method. (1) The processing method shall be one that 
has been shown to yield consistently a specific, potent final product, 
free of properties that would adversely affect the product for its 
intended use throughout its dating period.
    (2) Anti-IgG, -C3d (polyspecific) reagents and anti-IgG products may 
be colored green.
    (3) Only that material which has been fully processed, thoroughly 
mixed in a single vessel, and filtered shall constitute a lot. Each lot 
shall be identified by a lot number.
    (4) A lot may be subdivided into sublots which shall be identified 
by the lot number to which has been added a distinctive prefix or 
suffix. If lots are to be subdivided, the manufacturer

[[Page 130]]

shall include this information in the license application . The 
manufacturer shall describe the test specifications to verify that each 
sublot is identical to other sublots of the lot.
    (b) Final containers and dropper assemblies. (1) Final containers 
and dropper assemblies shall be clean.
    (2) Final containers and dropper pipettes shall be colorless and 
sufficiently transparent to permit observation of the contents for 
presence of particulate matter or increased turbidity.
    (c) Date of manufacture. The date of manufacture shall be the date 
the manufacturer begins the last entire group of potency tests.

[50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 65 
FR 77499, Dec. 12, 2000; 67 FR 9587, Mar. 4, 2002]