TY - BOOK AU - Garner,Willa Y. AU - Barge,Maureen S. AU - Ussary,James P. ED - American Chemical Society. TI - Good laboratory practice standards: applications for field and laboratory studies T2 - ACS professional reference book SN - 0841221928 AV - RA1199 .G37 1991 PY - 1992/// CY - Washington, DC PB - American Chemical Society KW - Toxicology laboratories KW - Standards KW - Laboratories KW - standards KW - United States KW - United States legislation KW - Toxicology KW - Sampling Studies KW - Pesticide residues KW - Quality control KW - Research Design N1 - 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 ER -