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. 03 - Frequency of Quality Assurance Inspections (PDF)(3 pp, 32 K)
- GLP Regulations Advisory No. 13 - Frequency of Quality Assurance audits at multiple test sites (PDF)(3 pp, 39 K)
- GLP Regulations Advisory No. 34 - Number of compliance statements and Quality Assurance reports (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 48 - Quality Assurance Unit's responsibilities (PDF)(2 pp, 30 K)
- GLP Regulations Advisory No. 52 - Quality Assurance Unit function (PDF)(3 pp, 26 K)
- GLP Regulations Advisory No. 66 - Clarification of Advisories 52 and 59 (PDF)(3 pp, 24 K)
- GLP Regulations Advisory No. 68 - Clarification of reporting protocols by QAU inspections (PDF)(3 pp, 23 K)
- GLP Regulations Advisory No. 79 - GLPS compliance statement for interim reports (40 CFR sec. 160.12) (PDF)(2 pp, 19 K)