[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: 21CFR600.10]

[Page 8-9]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600_BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                    Subpart B_Establishment Standards
 
Sec.  600.10  Personnel.


    (a) [Reserved]
    (b) Personnel. Personnel shall have capabilities commensurate with 
their assigned functions, a thorough understanding of the manufacturing 
operations which they perform, the necessary training and experience 
relating to individual products, and adequate information concerning the 
application of the pertinent provisions of this subchapter to their 
respective functions. Personnel shall include such professionally 
trained persons as are necessary to insure the competent performance of 
all manufacturing processes.
    (c) Restrictions on personnel--(1) Specific duties. Persons whose 
presence can affect adversely the safety and purity of a product shall 
be excluded from the room where the manufacture of a product is in 
progress.
    (2) Sterile operations. Personnel performing sterile operations 
shall wear clean or sterilized protective clothing and devices to the 
extent necessary to protect the product from contamination.
    (3) Pathogenic viruses and spore-forming organisms. Persons working 
with viruses pathogenic for man or with spore-forming microorganisms, 
and

[[Page 9]]

persons engaged in the care of animals or animal quarters, shall be 
excluded from areas where other products are manufactured, or such 
persons shall change outer clothing, including shoes, or wear protective 
covering prior to entering such areas.
    (4) Live vaccine work areas. Persons may not enter a live vaccine 
processing area after having worked with other infectious agents in any 
other laboratory during the same working day. Only persons actually 
concerned with propagation of the culture, production of the vaccine, 
and unit maintenance, shall be allowed in live vaccine processing areas 
when active work is in progress. Casual visitors shall be excluded from 
such units at all times and all others having business in such areas 
shall be admitted only under supervision. Street clothing, including 
shoes, shall be replaced or covered by suitable laboratory clothing 
before entering a live vaccine processing unit. Persons caring for 
animals used in the manufacture of live vaccines shall be excluded from 
other animal quarters and from contact with other animals during the 
same working day.

[38 FR 32048, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997; 68 FR 75119, Dec. 
30, 2003]