This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.29]
[Page 311-312]
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 312]]
(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.