[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: 21CFR58.130]
[Page 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
Subpart G Protocol for and Conduct of a Nonclinical Laboratory Study
Sec. 58.130 Conduct of a nonclinical laboratory study.
(a) The nonclinical laboratory study shall be conducted in
accordance with the protocol.
(b) The test systems shall be monitored in conformity with the
protocol.
(c) Specimens shall be identified by test system, study, nature, and
date of collection. This information shall be located on the specimen
container or shall accompany the specimen in a manner that precludes
error in the recording and storage of data.
(d) Records of gross findings for a specimen from postmortem
observations should be available to a pathologist when examining that
specimen histopathologically.
(e) All data generated during the conduct of a nonclinical
laboratory study, except those that are generated by automated data
collection systems, shall be recorded directly, promptly, and legibly in
ink. All data entries shall be dated on the date of entry and signed or
initialed by the person entering the data. Any change in entries shall
be made so as not to obscure the original entry, shall indicate the
reason for such change, and shall be dated and signed or identified at
the time of the change. In automated data collection systems, the
individual responsible for direct data input shall be identified at the
time of data input. Any change in automated data entries shall be made
so as not to obscure the original entry, shall indicate the reason for
change, shall be dated, and the responsible individual shall be
identified.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987;
67 FR 9585, Mar. 4, 2002]
Subparts H-I [Reserved]
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