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. 01 - Solubility studies (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 10 - Compliance of test substance (PDF)(3 pp, 31 K)
- GLP Regulations Advisory No. 11 - Compliance of non-study generated data (PDF)(2 pp, 30 K)
- GLP Regulations Advisory No. 14 - Compliance of confirmatory method trials (PDF)(3 pp, 39 K)
- GLP Regulations Advisory No. 18 - Study protocol, number per study (PDF)(3 pp, 38 K)
- GLP Regulations Advisory No. 19 - General questions on GLP interpretation (PDF)(2 pp, 37 K)
- GLP Regulations Advisory No. 28 - Efficacy studies compliance (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 29 - Exploratory studies compliance (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 30 - Analysis of test substance mixture (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 32 - Analysis of test substance mixture (PDF)(4 pp, 28 K)
- GLP Regulations Advisory No. 33 - Method revaluation compliance (PDF)(3 pp, 25 K)
- GLP Regulations Advisory No. 39 - Generic protocol (PDF)(3 pp, 23 K)
- GLP Regulations Advisory No. 43 - One trial one location (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 45 - Test substance definition (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 46 - Test facility description (PDF)(3 pp, 33 K)
- GLP Regulations Advisory No. 47 - Self-carbonized copies for exact copies (PDF)(2 pp, 31 K)
- GLP Regulations Advisory No. 49 - Multi-testing reporting requirements (PDF)(4 pp, 35 K)
- GLP Regulations Advisory No. 53 - Signature and date thereof on final report (PDF)(2 pp, 22 K)
- GLP Regulations Advisory No. 55 - Test, control and reference substance characterization (PDF)(3 pp, 25 K)
- GLP Regulations Advisory No. 58 - FIFRA GLPS Compliance by Interregional Research Project No. 4 (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 64 - Performance of characterization as separates or parts of (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 65 - Characterization of test substances and mixtures (PDF)(3 pp, 25 K)
- GLP Regulations Advisory No. 70 - Final reporting of tests ruled invalid (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 72 - Use of management as technicians in studies by small companies (PDF)(3 pp, 23 K)