Links
Links To Key Regulations, Guidelines & Related Sites
GOOD LABORATORY PRACTICE REGULATIONS
US EPA & FDA GLP
- 21 CFR 58 FDA Good Laboratory Practices for Non-clinical Laboratory Studies (2008)
- 40 CFR 160 EPA FIFRA Good Laboratory Practice Standards (2008)
- 40 CFR 792 EPA TSCA Good Laboratory Practice Standards (2008)
- Comparison Chart of FDA, EPA, and OECD GLP Regulations
- FDA GLP regulation 1978 PREAMBLE Federal Register
- FDA GLP regulation 1987 PREAMBLE Federal Register
- EPA GLP regulation 1989 PREAMBLE
International – GLP
- OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
- No.1 OECD Principles on Good Laboratory Practices (PDF)
- No.4 Quality Assurance and Good Laboratory Practices (PDF)
- No.8 The Roles and Responsibilities of Study Directors in GLP Studies (PDF)
- No.11 The Roles and Responsibilities of the Sponsor in the Application of Principles of GLP (PDF)
- No.13 Application of OECD Principles of GLP to Organization & Management of Multi-Site Studies(PDF)
- No.14 Application of Principles of GLP to InVitro Studies (PDF)
- No.15 Establishment & Control of Archives that Operate in Compliance with Principles of GLP (PDF)
- OECD Good Laboratory Practice, Publications & Documents
- Links to National Web Sites on Good Laboratory Practice (OECD)
BIOANALYTICAL GUIDANCE
FDA Guidance for Industry
- FDA Guidance – Bioanalytical Method Validation (PDF)
- FDA Guidance – Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -General Considerations (PDF)
BioAnalytical Articles
- Key Elements of Bioanalytical Method Validation for Small Molecules (PDF)
- Workshop/Conference Report – Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays (PDF)
- Best Practices During Bioanalytical Method Validation for the Characterization of Assay Reagents and the Evaluation of Analyte Stability in Assay Standards, Quality Controls, and Study Samples (PDF)
- Procedural Elements Involved in Maintaining Bioanalytical Data Integrity for Good Laboratory Practices Studies and Regulated Clinical Studies (PDF)
- The History of Bioanalytical Method Validation and Regulation: Evolution of aGuidance Document on Bioanalytical Methods Validation (PDF)
- Confi rmatory Reanalysis of Incurred Bioanalytical Samples (PDF)
REGULATIONS AND GUIDANCE
- Code of Federal Regulations
- Federal Food, Drug, and Cosmetic Act
- FDA CDER Glossary of Terms
- FDA CDER (Drug) Guidance Documents
- FDA CBER (Biologics) Guidance Documents
- FDA CDER Regulatory Pharmacology & Toxicology Guidelines
- EPA Pesticide Registration (PR) Notices
- EPA Pesticide Registration (PR) Notice 97-1
- EPA OPPTS Harmonized Test Guidelines
- OECD Guidelines for the Testing of Chemicals
- OECD Guidelines for the Testing of Chemicals – Full List of Test Guidelines (PDF)