21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies

§ 58.190 Storage and retrieval of records and data

Subpart J - Records and Reports Official text on eCFR Amendment history

(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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 58.190

Form FDA 483 observations citing this section, fiscal years 2014–2014 (Bioresearch Monitoring).

  • Archives: data, documentation, specimens 1

Warning letters citing § 58.190

5 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 58.190

Amendment history

Federal Register documents that created or amended this section.