Good Laboratory Practice Standards

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.

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
Table of Contents provided by Publisher. All Rights Reserved.

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Good Laboratory Practice Standards Applications for Field and Laboratory Studies

Summary

Table of Contents

Supplemental Materials