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Good Laboratory Practice Regulations Third Edition, Revised and Expanded
Sandy Weinberg


ISBN: 0824708911 | Year 2003 | English
264pages | pdf | size:2,83Mb


Exploring the role of Good Laboratory Practices (GLP) in the assurance of safety, quality, and control in regulated arenas, this reference details specific standards and general guidelines for the management of efficient and effective research environments-presenting essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

The Third Edition of Good Laboratory Practice Regulations contains current material on the utilization and implementation of 21 CFR Part 11 guidelines for LIMS and other computerized laboratory systems…the effects of automation of GLP practices…and the application of GLP standards to non-GLP laboratories…and analyzes GLP enforcement…the FDA`s GLP Inspection Program…the ability of GLP to advance along with the ever-changing functions of laboratory operation, supervision, and maintenance…and the impact of GLP on research, production, and clinical testing.

Table of Contents:
• Historical Perspective by Jean M. Taylor and Gary C. Stein
• FDA/ GLP Regulations by Wendell A. Peterson
• Applying 21 CFR Part 11 to the Laboratory Environment by Sandy Weinberg
• The Good Automated Laboratory Practices by Gerald J. Whartenby, Paul L. Robinson, and Sandy Weinberg
• Implementing GLP’s in a Non-GLP Analytical Laboratory by Stephanie A. Olexa
• Computer Systems Validation by Sandy Weinberg
• The FDA’s GLP Inspection Program by George W. James
• The Future by Sandy Weinberg
• Bibliography
• Index

Good Laboratory Practice Regulations,Third Edition