[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.29]



[Page 304-305]

 

                        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.

    (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



[[Page 305]]



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.