Good Laboratory Practice Standards: Applications for Field and Laboratory Studies / Edition 1

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Overview

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.

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Editorial Reviews

Booknews
To the companies that manufacture agrochemicals and to the scientists who test the health and environmental effects of these chemicals, the Good Laboratory Practice (GLP) Standards revisions, which were enacted in October 1989, mean that GLPs are no longer simply an option, but rather are an operational requirement. Representing industry, field and laboratory research, and government agencies, contributions outline approaches for successful compliance and avoidance of common mistakes. Appendices contain the text of the GLP Standards, forms for submitting data, a question-and-answer section, and the EPA's recently enacted penalty policy. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780841221925
  • Publisher: American Chemical Society
  • Publication date: 5/28/1992
  • Series: ACS Professional Reference Book Series
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 571
  • Product dimensions: 6.10 (w) x 9.30 (h) x 1.50 (d)

Meet the Author

GARNDAL Associates

FMC Corporation

Ussary Scientific Services

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Table of Contents

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

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