Good laboratory practice standards : applications for field and laboratory studies / edited by Willa Y. Garner, Maureen S. Barge, James P. Ussary

Includes bibliographical references and indexes

Overview. 1. Responding to Regulatory Changes in Agrochemical Research / Joseph B. Townsend -- Good Laboratory Practice Requirements. 2. Management Commitment to the Good Laboratory Practices Process / Maureen S. Barge. 3. Preparing Standard Operating Procedures for Field Studies / James P. Ussary. 4. Preparing Standard Operating Procedures for the Laboratory / M. Jean Hornshuh. 5. Designing Protocols for Field Studies / Maureen S. Barge. 6. Practical Protocols for the Laboratory / Gene Burnett. 7. Test Substance and Specimen Chain of Custody in Field Studies / Markus M. Jensen. 8. Practical Applications for Chain of Custody Within an Analytical Laboratory / Robert J. Pollock. 9. Test Substance and Analytical Reference Standard Characterization and AccountabIlity / S. Rand Fuller and Willa Y. Garner. 10. Reporting Study Results / Judy H. Hochman and Willa Y. Garner -- Quality Assurance Responsibilities 11. The Quality Assurance Unit: The Master Schedule and the Archives / Patricia D. Royal. 12. Facility Inspection Conduct: Quality Assurance Perspective for Field Studies / David Johnson and Jesse Burton. 13. Analytical Phase Inspection of Residue Chemistry and Environmental Studies / Frances A. Dillon and Jeffery L. Harris. 14. Data Audits for Field Studies / Del W. Huntsinger. 15. Laboratory Data Auditing / Harry L. Hyndman -- Computer Validation. 16. Working Models of Computer System Validation and Verification / Phillip M. Buckler. 17. Validation of Laboratory Computer Software / J. Drew Watson -- Specialty Studies. 18. Product Chemistry from the Formulation Perspective / John F. Wright. 19. Compliance for Routine and Nonroutine Field Studies / James P. Ussary. 20. Nonbiased Field Sampling / Duane D. Ewing. 21. Processing Studies / Malcolm F. Gerngross. 22. Livestock Studies / Gino J. Marco, Roger A. Novak and Judy H. Hochman 23. Specialized Field Testing: Worker Protection / D. Larry Merricks, Donna H. Merricks and William C. Spare. 24. Mesocosm Studies and Other Aquatic Field Studies with Pesticides / Jeffrey M. Giddings. 25. Terrestrial Field Studies / Mary E. Johnson and Mark Jaber. 26. Problems with Ecotoxicological Field Studies / John A. McCann. 27. Agrochemical Groundwater Studies / Sandra C. Cooper and James M. DeMartinis. 28. Runoff Studies / Peter N. Coody -- Regulatory Impact. 29. Auditing Field Studies: Government Perspective / Dean F. Hill. 30. Is the Federal Insecticide, Fungicide, and Rodenticide Act Good Laboratory Practices Program at a Crossroads? / David L. Dull and Francisca E. Liem. 31. Good Laboratory Practice Standards Policies and Interpretations / Phyllis E. Flaherty and Stephen J. Howie. 32. Economic Impact of Regulations on Field Contractors and an Agrochemical Company / James L. Platt, Jr. 33. Harmonization and Prospects for the Future / Frederick G. Snyder App. A. Federal Insecticide, Fungicide, and Rodenticide Act; GLP Standards -- App. B.U.S. Environmental Protection Agency FIFRA Advisories / Willa Y. Garner -- App. C. The EPA Enforcement Response Policy for the FIFRA Good Laboratory Practice Standards -- App. D. Representative Forms Used by Companies for Compliance with GLP Standards