[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.29]

[Page 303-304]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents
 
                  Subpart B_Organization and Personnel
 
Sec. 58.29  Personnel.


    (a) Each individual engaged in the conduct of or responsible for the 
supervision of a nonclinical laboratory study shall have education, 
training, and experience, or combination thereof, to enable that 
individual to perform the assigned functions.
    (b) Each testing facility shall maintain a current summary of 
training and experience and job description for each individual engaged 
in or supervising the conduct of a nonclinical laboratory study.
    (c) There shall be a sufficient number of personnel for the timely 
and proper conduct of the study according to the protocol.
    (d) Personnel shall take necessary personal sanitation and health 
precautions designed to avoid contamination of test and control articles 
and test systems.

[[Page 304]]

    (e) Personnel engaged in a nonclinical laboratory study shall wear 
clothing appropriate for the duties they perform. Such clothing shall be 
changed as often as necessary to prevent microbiological, radiological, 
or chemical contamination of test systems and test and control articles.
    (f) Any individual found at any time to have an illness that may 
adversely affect the quality and integrity of the nonclinical laboratory 
study shall be excluded from direct contact with test systems, test and 
control articles and any other operation or function that may adversely 
affect the study until the condition is corrected. All personnel shall 
be instructed to report to their immediate supervisors any health or 
medical conditions that may reasonably be considered to have an adverse 
effect on a nonclinical laboratory study.