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. 02 - Samples, retention times and schedules (PDF)(3 pp, 33 K)
- GLP Regulations Advisory No. 07 - Retention of soil samples (PDF)(2 pp, 30 K)
- GLP Regulations Advisory No. 09 - Retention time for wet specimens, Number of signatures on compliance statement and Test substance metabolites listed in protocol (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 16 - Retention of reserve test substance samples (PDF)(2 pp, 30 K)
- GLP Regulations Advisory No. 36 - Retention time of wet specimens (PDF)(61 pp, 234 K)
- GLP Regulations Advisory No. 50 - Test sample substance retention (PDF)(3 pp, 33 K)
- GLP Regulations Advisory No. 57 - Raw old study data retention for new study (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 60 - Retention of original storage containers (PDF)(4 pp, 27 K)
- GLP Regulations Advisory No. 62 - Test substance container retention and surplus substance use (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 76 - Raw data retention periods for TSCA/GLPs (PDF)(3 pp, 22 K)
- GLP Regulations Advisory No. 83 - Retention of raw data in support of pesticide registration (PDF)(3 pp, 55 K)