[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.33]
[Page 306-307]
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
Subpart B Organization and Personnel
Sec. 58.33 Study director.
For each nonclinical laboratory study, a scientist or other
professional of appropriate education, training, and experience, or
combination thereof, shall be identified as the study director. The
study director has overall responsibility for the technical conduct
[[Page 307]]
of the study, as well as for the interpretation, analysis, documentation
and reporting of results, and represents the single point of study
control. The study director shall assure that:
(a) The protocol, including any change, is approved as provided by
Sec. 58.120 and is followed.
(b) All experimental data, including observations of unanticipated
responses of the test system are accurately recorded and verified.
(c) Unforeseen circumstances that may affect the quality and
integrity of the nonclinical laboratory study are noted when they occur,
and corrective action is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are
followed.
(f) All raw data, documentation, protocols, specimens, and final
reports are transferred to the archives during or at the close of the
study.
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]
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