[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: 21CFR58.190]



[Page 311]

 

                        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]