GLP Quality Consulting, LLC

Below are listed some suggested resources for more information on Good Laboratory Practices:

FDA

• FDA Good Laboratory Practices (21 CFR Part 58) Current (HTML)
• FDA Good Laboratory Practices Proposed Rule 11/19/1976 (PDF)
• FDA Good Laboratory Practices Final Rule 1978 (PDF)
• FDA Good Laboratory Practices Proposed Rule 10/29/1984 (PDF)
• FDA Good Laboratory Practices Final Rule 9/4/1987 (PDF)
• Good Laboratory Practices Regulations -Management Briefings Post Conference Report (Aug. 1979) (PDF)
• GLP Questions and Answers (PDF)
• FDA GLP Compliance Program Guidance Manual (HTML)  (PDF)
• Guidance for Industry-Pharmacology/Toxicology (HTML) 
• Bioanalytical Method Validation Guidance  (PDF)

EPA

• EPA FIFRA GLPs (40 CFR Part 160) (HTML)
• EPA TSCA GLPs (40 CFR 792) (HTML)
• EPA GLP Advisories (HTML)
• EPA GLP Questions and Answers (HTML)

OECD

• OECD Principles of Good Laboratory Practice (PDF)

Other Resources

• Links to International Websites on GLP (HTML)
• ICH Guidances-Safety and Quality (HTML)
• Electronic Records/Signatures 21 CFR Part 11 (HTML)
• Workshop/Conference Report Qualitative Bioanalytical Methods Validation and Implementation (Crystal City 2007) (PDF)
• Society of Quality Assurance (SQA)
• Regulatory Affairs Professionals Society (RAPS)
• Comparison Chart of FDA, EPA, and OECD GLP requirements  (PDF)