Good Labratory Practice (GLP)
In the US, the GLPs are regulated quality standards that are designed to ensure the quality, integrity and reliability of non-clinical test data submitted to federal agencies in support of a research or marketing permit under federal law. GLPs encompass both lab and field research and dictate the organization, process, and conditions under which studies are planned performed, monitored, recorded, and reported.
GLP product research may include FDA regulated and monitored studies, such as drugs for human and animal use, aroma and color additives in food, cosmetics, biological products, dietary supplements and medical devices and EPA regulated and monitored studies, such as pesticides, insecticides, fungicides, and toxic substances. GLPs can be applied to guideline and non-guideline studies.
CSU Training / Services
- GLP Training: Individual Lab or class GLP training available.
- Facility/Study Inspections: Services available as needed.
US Regulatory References
- 21 CFR Part 58 (FDCA; food, drugs and cosmetics)
- EPA 40 CFR Part 160 (FIFRA; fungicides, insecticides, rodenticides, etc .)
- 40 CFR Part 792 (TSCA; toxic substances)
- OECD Series on Principles of GLP and Compliance Monitoring (Internationally recognized consensus documents for the conduct of GLP studies by the Organisation for Economic Co-operation and Development (OECD))
- Comparison Chart (FDA, EPA and OECD GLP)
- FDA GLP Home Page
- FDA Bioresearch Monitoring (BIMO) Program
- FDA 1981 Questions & Answers
“Since June 20, 1979, the agency has been asked many questions on the Good Laboratory Practice regulations (GLPs, 21 CFR 58). In accord with agency
procedures, responses have been prepared and copies of the associated correspondence have been filed in the Dockets Management Branch (HFA-305). The
responses have also been provided to the bioresearch monitoring program managers and to the district offices in order to ensure consistency of
interpretation and equity of program operation.”
- FDA Application Integrity Policy (Inspections, Compliance, Enforcement, and Criminal Investigations)
- FDA List of Inspected Facilities
- EPA GLP Home Page
- EPA GLP Advisories “The EPA 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.”
- FIFRA GLP Enforcement Policy
- TSCA GLP Enforcement Response Policy
- EPA List of GLP Violations
- EPA List of Inspected Facilities