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

Hardcover (Print)

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

List of Figures and Tables
Preface
Overview
1 Responding to Regulatory Changes in Agrochemical Research 3
Good Laboratory Practice Requirements
2 Management Commitment to the Good Laboratory Practices Process 13
3 Preparing Standard Operating Procedures for Field Studies 21
4 Preparing Standard Operating Procedures for the Laboratory 27
5 Designing Protocols for Field Studies 43
6 Practical Protocols for the Laboratory 53
7 Test Substance and Specimen Chain of Custody in Field Studies 85
8 Practical Applications for Chain of Custody Within an Analytical Laboratory 95
9 Test Substance and Analytical Reference Standard Characterization and AccountabIlity 113
10 Reporting Study Results 127
Quality Assurance Responsibilities
11 The Quality Assurance Unit: The Master Schedule and the Archives 143
12 Facility Inspection Conduct: Quality Assurance Perspective for Field Studies 155
13 Analytical Phase Inspection of Residue Chemistry and Environmental Studies 163
14 Data Audits for Field Studies 175
15 Laboratory Data Auditing 181
Computer Validation
16 Working Models of Computer System Validation and Verification 203
17 Validation of Laboratory Computer Software 217
Specialty Studies
18 Product Chemistry from the Formulation Perspective 227
19 Compliance for Routine and Nonroutine Field Studies 235
20 Nonbiased Field Sampling 241
21 Processing Studies 249
22 Livestock Studies 257
23 Specialized Field Testing: Worker Protection 279
24 Mesocosm Studies and Other Aquatic Field Studies with Pesticides 297
25 Terrestrial Field Studies 309
26 Problems with Ecotoxicological Field Studies 317
27 Agrochemical Groundwater Studies 333
28 Runoff Studies 343
Regulatory Impact
29 Auditing Field Studies: Government Perspective 361
30 Is the Federal Insecticide, Fungicide, and Rodenticide Act Good Laboratory Practices Program at a Crossroads? 375
31 Good Laboratory Practice Standards Policies and Interpretations 387
32 Economic Impact of Regulations on Field Contractors and an Agrochemical Company 399
33 Harmonization and Prospects for the Future 419
App. A. Federal Insecticide, Fungicide, and Rodenticide Act; GLP Standards 433
App. B. U.S. Environmental Protection Agency FIFRA Advisories 445
App. C. The EPA Enforcement Response Policy for the FIFRA Good Laboratory Practice Standards 475
App. D. Representative Forms Used by Companies for Compliance with GLP Standards 501
Author Index 557
Affiliation Index 557
Subject Index 558
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