Good Laboratory Practice Regulations
FDA-GLP
21CFRPart58 FDA - Good Laboratory Practices for Non-clinical Laboratory Studies (April 2007)
Part 58 by section
EPA-GLP
40CFRPart160 FIFRA Good Laboratory Practice Standards (July 2007) Part 160 by section
40CFRPart792 TSCA Good Laboratory Practice Standards (July 2007) Part792 by section
International - GLP
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
No.1 OECD Principles on Good Laboratory Practices
No. 4 Quality Assurance and Good Laboratory Practices
No. 8 The Roles and Responsibilities of Study Directors in GLP Studies
No. 11 The Roles and Responsibilities of the Sponsor in the Application of Principles of GLP
No. 13 Application of OECD Principles of GLP to Organization and Management of Multi-Site Studies
No. 14 Application of Principles of GLP to InVitro Studies
No. 15 Establishment and Control of Archives that Operate in Compliance with Principles of GLP
Good Laboratory Practice, Publications & Documents
BioAnalytical Guidance
FDA Bioanalytical Method Validation Guidance doc
FDA Guidance Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -General Considerations
Key Elements of Bioanalytical Method Validation for Small Molecules
Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
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
Procedural Elements Involved in Maintaining Bioanalytical Data Integrity for Good Laboratory Practices Studies and Regulated Clinical Studies
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
Links to National Web Sites on Good Laboratory Practice
International Conference on Harmonization
ICH Topics and Guidelines
Other Sources
Food and Drug Administration
Environmental Protection Agency
American Association of Pharmaceutical Scientists (AAPS)
The AAPS Journal
Society of Quality Assurance
MidWest Regional Chapter—Society of Quality Assurance
www.labcompliance.com
21CFRPart11.com (NuGenesis Technologies)
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