Good Laboratory Practice Regulations, Third Edition, Revised and Expanded

Front Cover
CRC Press, Nov 6, 2002 - Medical - 264 pages
0 Reviews
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
 

What people are saying - Write a review

We haven't found any reviews in the usual places.

Contents

Chapter 1 Historical Perspective
1
Chapter 2 FDAGLP Regulations
25
Chapter 3 Applying 21 CFR Part 11 to the Laboratory Environment
115
Chapter 4 The Good Automated Laboratory Practices
127
Chapter 5 Implementing GLPs in a NonGLP Analytical Laboratory
149
Chapter 6 Computer Systems Validation
165
Chapter 7 The FDAs GLP Inspection Program
197
Chapter 8 The Future
217
Bibliography
229
Index
239
Copyright

Other editions - View all

Common terms and phrases

Bibliographic information