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. 05 - Container storage maintenance (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 21 - Storage of test substance mixed with carrier (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 23 - Test substance storage stability (PDF)(3 pp, 31 K)
- GLP Regulations Advisory No. 24 - Test substance container storage (PDF)(4 pp, 36 K)
- GLP Regulations Advisory No. 25 - Test substance container storage (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 26 - Test substance container storage (PDF)(4 pp, 36 K)
- GLP Regulations Advisory No. 27 - Test substance container storage (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 37 - Maintenance of test substance container storage (PDF)(3 pp, 22 K)
- GLP Regulations Advisory No. 40 - Test substance container storage (PDF)(4 pp, 26 K)
- GLP Regulations Advisory No. 41 - Test substance container storage (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 51 - Test substance container storage (PDF)(3 pp, 25 K)
- GLP Regulations Advisory No. 56 - Test material storage requirements (PDF)(4 pp, 26 K)
- GLP Regulations Advisory No. 63 - Disposition of used test substance containers (PDF)(4 pp, 27 K)
- GLP Regulations Advisory No. 67 - Test substance storage containers (PDF)(4 pp, 27 K)
- GLP Regulations Advisory No. 74 - Retention of empty storage containers - excessive numbers thereof (PDF)(5 pp, 28 K)
- GLP Regulations Advisory No. 77 - Storage stability studies (40 CFR sec. 160.135(a) and 40 CFR sec. 160.135(b)) (PDF)(2 pp, 19 K)
- GLP Regulations Advisory No. 78 - Retention of test substance containers (40 CFR sec. 160.105(c)) (PDF)(4 pp, 26 K)
- GLP Regulations Advisory No. 81 - est substance storage containers 40 CFR sec. 160.105(c) exception (PDF)(4 pp, 25 K)
- GLP Regulations Advisory No. 82 - Retention and retaining reserve samples from each batch of test substance (40 CFR sec. 160.195) (PDF)(4 pp, 58 K)