GLP Support Services

REGULATORY AGENCY WEBSITES

• Food and Drug Administration (FDA): www.fda.gov
• Environmental Protection Agency (EPA): www.epa.gov
• Organisation for Economic Co-operation and Development (OECD):  www.oecd.org
• World Health Organization (WHO):  www.who.int/en/
• International Conference on Harmonization (ICH):  www.ich.org

GOOD LABORATORY PRACTICE (GLP) REGULATIONS

• Comparison Chart of FDA,  EPA, and OECD GLP Regulations: www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133724.pdf

FDA GLP Regulations

• FDA GLP regulation 1987 PREAMBLE Federal Register: www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/NonclinicalLaboratoriesInspectedunderGoodLaboratoryPractices/ucm072706.htm
• FDA’s Guidance for Industry, “Good Laboratory Practices Questions and Answers”:  http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133748.pdf
• 21 CFR 58 FDA Good Laboratory Practices for Non-clinical Laboratory Studies: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1

EPA GLP Regulations

• 40 CFR 160 EPA FIFRA Good Laboratory Practice Standards: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=b2563e7aff3509ea2f12090833da21e9&rgn=div5&view=text&node=40:25.0.1.1.11&idno=40
• 40  CFR 792 EPA TSCA Good Laboratory Practice Standards: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=779de53e2241a98322907d90c39f37e5&rgn=div5&view=text&node=40:33.0.1.1.3&idno=40

OECD and WHO GLP Regulations

• OECD GLP home page: www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/goodlaboratorypracticeglp.htm
• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm
• OECD Chemical Safety: Links to National Web Sites on Good Laboratory Practice (OECD): www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/linkstonationalwebsitesongoodlaboratorypractice.htm
• OECD Guidelines for the Testing of Chemicals: www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/oecdguidelinesforthetestingofchemicals.htm
• World Health Organization (WHO) – GLP Handbook: www.who.int/tdr/publications/documents/glp-handbook.pdf

INTERNATIONAL CONFERENCE ON HARMONIZATION

• ICH Topics and Guidelines: www.ich.org/products/guidelines

REGULATIONS AND GUIDANCE DOCUMENTS

• Federal Food, Drug, and Cosmetic Act: www.fda.gov/opacom/laws/fdcact/fdctoc.htm
• FDA Glossary of Terms: www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
• FDA CDER (Drug) Guidance Documents: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
  • FDA CBER (Biologics) Guidance Documents: www.fda.gov/cber/guidelines.htm
  • FDA CDER Regulatory Pharmacology & Toxicology Guidelines; www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065014.htm
• EPA OPPTS Harmonized Test Guidelines: www.epa.gov/ocspp/pubs/frs/home/guidelin.htm

OTHER SOURCES

• Society of Quality Assurance (SQA): www.sqa.org
• Code of Federal Regulations (Annual Edition – starting 1996): www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
• Electronic Code of Federal Regulations (e-CFR): http://ecfr.gpoaccess.gov