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: 21CFR58.190]
[Page 318]
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 J--Records and Reports
Sec. 58.190 Storage and retrieval of records and data.
(a) All raw data, documentation, protocols, final reports, and
specimens (except those specimens obtained from mutagenicity tests and
wet specimens of blood, urine, feces, and biological fluids) generated
as a result of a nonclinical laboratory study shall be retained.
(b) There shall be archives for orderly storage and expedient
retrieval of all raw data, documentation, protocols, specimens, and
interim and final reports. Conditions of storage shall minimize
deterioration of the documents or specimens in accordance with the
requirements for the time period of their retention and the nature of
the documents or specimens. A testing facility may contract with
commercial archives to provide a repository for all material to be
retained. Raw data and specimens may be retained elsewhere provided that
the archives have specific reference to those other locations.
(c) An individual shall be identified as responsible for the
archives.
(d) Only authorized personnel shall enter the archives.
(e) Material retained or referred to in the archives shall be
indexed to permit expedient retrieval.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987;
67 FR 9585, Mar. 4, 2002]