Good Laboratory Practice Standards: Applications for Field and Laboratory Studies - Rilegato

Rilegato

ISBN 10: 0841221928 ISBN 13: 9780841221925

Casa editrice: American Chemical Society, 1992

Riassunto

Written by experienced quality assurance (QA) professionals and field laboratory researchers. Provides concrete ideas for establishing a compliance program and refining the compliance process. Outlines approaches that have resulted in successful compliance and describes methods of avoiding some of the common mistakes. Appendices contain the entire GLP Enforcement Response Policy, a question-and-answer section, examples of forms for submitting data to the EPA, and the EPA's penalty policy.

Su questo libro

Contenuti

• Responding to Regulatory Changes in Agrochemical Research
• Management Commitment to the Good Laboratory Practices Process
• Preparing Standard Operating Procedures for Field Studies
• Preparing Standard Operating Procedures for the Laboratory
• Designing Protocols for Field Studies
• Practical Protocols for the Laboratory
• Test Substance and Specimen Chain of Custody in Field Studies
• Practical Applications for Chain of Custody Within an Analytical Laboratory
• Test Substance and Analytical Reference Standard Characterization and Accountability
• Reporting Study Results
• The Quality Assurance Unit: The Master Schedule and the Archives
• Facility Inspection Conduct: Quality Assurance Perspective for Field Studies
• Analytical Phase Inspection of Residue Chemistry and Environmental Studies
• Data Audits for Field Studies
• Laboratory Data Auditing
• Working Models of Computer System Validation and Verification
• Validation of Laboratory Computer Software
• Product Chemistry from the Formulation Perspective
• Compliance for Routine and Nonroutine Field Studies
• Nonbiased Field Sampling
• Processing Studies
• Livestock Studies
• Specialized Field Testing: Worker Protection
• Mesocosm Studies and Other Aquatic Field Studies with Pesticides
• Terrestrial Field Studies
• Problems with Ecotoxicological Field Studies
• Agrochemical Groundwater Studies
• Runoff Studies
• Auditing Field Studies: Government Perspective
• Is the Federal Insecticide, Fungicide, and Rodenticide Act Good Laboratory Practices Program at a Crossroads?
• Good Laboratory Practice Standards Policies and Interpretations
• Economic Impact of Regulations on Field Contractors and an Agrochemical Company
• Harmonization and Prospects for the Future

Dettagli dell'edizione

• Editore: American Chemical Society
• Data di pubblicazione: 1992
• Lingua: Inglese
• ISBN 10: 0841221928
• ISBN 13: 9780841221925
• Rilegatura: Copertina rigida
• Numero di pagine: 571
• Redattore: Garner Willa Y., Barge Maureen S., Ussary James P.
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile