The laboratory inspection/data audit program monitors the regulated community, who periodically raise questions related to the interpretation of the Good Laboratory Practices (GLP) regulations. Inspectors and other interested personnel have also asked EPA for guidance on the regulations. Often the questions are relatively simple and straight forward to which all inspectors would provide a uniform and consistent reply. However, there are instances when several interpretations are possible or clarification may be necessary. The purpose of the advisories is to provide that clarification.
What follows are interpretations of the GLP regulations as issued by the Office of Compliance. This interpretation is official policy in the GLP program and should be followed by all GLP inspectors.You will need Adobe Reader to view some of the files on this page. See EPA’s About PDF page to learn more.
- GLP Regulations Advisory No. 12 - Off-site archives (PDF)(3 pp, 39 K)
- GLP Regulations Advisory No. 31 - Archive of records-time/location/duration of study (PDF)(3 pp, 33 K)
- GLP Regulations Advisory No. 38 - Responsibility of archive (PDF)(2 pp, 21 K)
- GLP Regulations Advisory No. 42 - Archiving requirements—number of reports/protocols, Reference and control substances characterization (PDF)(5 pp, 37 K)
- GLP Regulations Advisory No. 44 - Archiving of raw data (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 54 - Archiving requirements (PDF)(2 pp, 22 K)
- GLP Regulations Advisory No. 61 - Archiving wet samples for extended periods (PDF)(3 pp, 25 K)
- GLP Regulations Advisory No. 75 - Archive of records of out of business companies (PDF)(2 pp, 21 K)