[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: 21CFR610.18]

[Page 75-76]
 
                        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 B_General Provisions
 
Sec.  610.18  Cultures.

    (a) Storage and maintenance. Cultures used in the manufacture of 
products shall be stored in a secure and orderly manner, at a 
temperature and by a method that will retain the initial characteristics 
of the organisms and insure freedom from contamination and 
deterioration.
    (b) Identity and verification. Each culture shall be clearly 
identified as to source strain. A complete identification of the strain 
shall be made for each new stock culture preparation. Primary and 
subsequent seed lots shall be identified by lot number and date of 
preparation. Periodic tests shall be performed as often as necessary to 
verify the integrity of the strain characteristics and freedom from 
extraneous organisms. Results of all periodic tests for verification of 
cultures and determination of freedom from extraneous organisms shall be 
recorded and retained.
    (c) Cell lines used for manufacturing biological products--(1) 
General requirements. Cell lines used for manufacturing biological 
products shall be:
    (i) Identified by history;
    (ii) Described with respect to cytogenetic characteristics and 
tumorigenicity;
    (iii) Characterized with respect to in vitro growth characteristics 
and life potential; and
    (iv) Tested for the presence of detectable microbial agents.
    (2) Tests. Tests that are necessary to assure the safety, purity, 
and potency of a product may be required by the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research.
    (3) Applicability. This paragraph applies to diploid and nondiploid 
cell lines. Primary cell cultures that are not subcultivated and primary 
cell cultures that are subsequently subcultivated for only a very 
limited number of population doublings are not subject to the provisions 
of this paragraph (c).
    (d) Records. The records appropriate for cultures under this section 
shall be prepared and maintained as required by

[[Page 76]]

the applicable provisions of Sec. Sec.  211.188 and 211.194 of this 
chapter.

[38 FR 32056, Nov. 20, 1973, as amended at 51 FR 44453, Dec. 10, 1986; 
55 FR 11013, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 
24, 2005]