{"id":44,"date":"2025-11-13T22:16:15","date_gmt":"2025-11-13T22:16:15","guid":{"rendered":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/quality-assurance\/good-laboratory-practices-glp\/"},"modified":"2025-11-13T22:34:02","modified_gmt":"2025-11-13T22:34:02","slug":"good-laboratory-practices-glp","status":"publish","type":"page","link":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/quality-assurance\/qa-services\/good-laboratory-practices-glp\/","title":{"rendered":"Good Laboratory Practices (GLP)"},"content":{"rendered":"\n<p>In the US, the GLPs are regulated quality standards that are designed to ensure the quality, integrity, and reliability of&nbsp;non-clinical&nbsp;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.<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"margin-bottom:3rem\">\n<ul class=\"wp-block-list is-style-green-border\">\n<li>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.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading\">CSU Training \/ Services<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GLP Training: Individual Lab or class GLP training available.<\/li>\n\n\n\n<li>Facility\/Study Inspections: Services available as needed.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading\">US Regulatory References<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2011-title40-vol24\/xml\/CFR-2011-title40-vol24-part160.xml\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR Part 58 (FDCA; food, drugs and cosmetics)<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2011-title40-vol24\/xml\/CFR-2011-title40-vol24-part160.xml\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>EPA 40 CFR Part 160 (FIFRA; fungicides, insecticides, rodenticides, etc .)<\/strong><\/a><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/CFR-2011-title40-vol32\/xml\/CFR-2011-title40-vol32-part792.xml\" target=\"_blank\" rel=\"noreferrer noopener\">40 CFR Part 792 (TSCA; toxic substances)<\/a><\/strong><\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading\">International References<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/good-laboratory-practiceglp.htm\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>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))<\/strong><\/a><\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading\">Helpful Links<\/h2>\n\n\n\n<p><strong><a href=\"http:\/\/www.fda.gov\/downloads\/ICECI\/EnforcementActions\/BioresearchMonitoring\/UCM133724.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Comparison Chart (FDA, EPA and OECD GLP)<\/a><\/strong><\/p>\n<\/div>\n\n\n\n<details class=\"wp-block-details is-style-details-outline is-layout-flow wp-block-details-is-layout-flow\"><summary>FDA<\/summary>\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/BioresearchMonitoring\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA GLP Home Page<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/BioresearchMonitoring\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Bioresearch Monitoring (BIMO) Program<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/nonclinical-laboratories-inspected-under-good-laboratory-practices\/1981-questions-answers-good-laboratory-practice-regulations\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FDA 1981 Questions &amp; Answers<\/strong><\/a><br><em><strong>\u201c<\/strong>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<br>procedures, responses have been prepared and copies of the associated correspondence have been filed in the Dockets Management Branch (HFA-305).<\/em><br><em>The responses have also been provided to the bioresearch monitoring program managers and to the district offices in order to ensure consistency of<br>interpretation and equity of program operation.\u201d<\/em><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/application-integrity-policy\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FDA Application Integrity Policy (Inspections, Compliance, Enforcement, and Criminal Investigations)<\/strong><\/a><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-references\/inspection-classification-database\" target=\"_blank\" rel=\"noreferrer noopener\">FDA List of Inspected Facilities<\/a><\/strong><\/li>\n<\/ul>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-style-details-outline is-layout-flow wp-block-details-is-layout-flow\"><summary>EPA<\/summary>\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.epa.gov\/compliance\/good-laboratory-practices-standards-compliance-monitoring-program\">EPA GLP Home Page<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/www.epa.gov\/compliance\/policy-good-laboratory-practices-advisories-compliance-monitoring\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>EPA GLP Advisories<\/strong><\/a><strong>&nbsp;<\/strong><br><em>\u201cThe EPA laboratory inspection\/data<br>audit program monitors the regulated community, who periodically raise questions related to the interpretation of the Good Laboratory Practices (GLP)<br>regulations. Inspectors and other interested personnel have also asked EPA for guidance on the regulations. Often the questions are relatively simple<br>and straight forward to which all inspectors would provide a uniform and consistent reply. However, there are instances when several interpretations<br>are possible or clarification may be necessary. The purpose of the advisories is to provide that clarification.\u201d<\/em><\/li>\n\n\n\n<li><a href=\"https:\/\/www.epa.gov\/enforcement\/enforcement-response-policy-erp-federal-insecticide-fungicide-and-rodenticide-act-fifra\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FIFRA GLP Enforcement Policy<\/strong><\/a><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/www.epa.gov\/enforcement\/final-tsca-glp-enforcement-response-policy\" target=\"_blank\" rel=\"noreferrer noopener\">TSCA GLP Enforcement Response Policy<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2013-09\/documents\/glpstudyrejection.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EPA List of GLP Violations<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/echo.epa.gov\/facilities\/facility-search\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>EPA List of Inspected Facilitie<\/strong>s<\/a><\/li>\n<\/ul>\n<\/details>\n","protected":false},"excerpt":{"rendered":"<p>In the US, the GLPs are regulated quality standards that are designed to ensure the quality, integrity, and reliability of&nbsp;non-clinical&nbsp;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, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"microsite":[6],"class_list":["post-44","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/44","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/comments?post=44"}],"version-history":[{"count":0,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/44\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/pages\/38"}],"wp:attachment":[{"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/media?parent=44"}],"wp:term":[{"taxonomy":"microsite","embeddable":true,"href":"https:\/\/www.research.colostate.edu\/integrity-security-compliance\/wp-json\/wp\/v2\/microsite?post=44"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}