This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility an
Good Laboratory Practice Regulations
โ Scribed by Sandy Weinberg (ed.)
- Publisher
- CRC Press
- Year
- 2002
- Tongue
- English
- Leaves
- 244
- Series
- Drugs and the Pharmaceutical Sciences
- Edition
- 3
- Category
- Library
No coin nor oath required. For personal study only.
โฆ Synopsis
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.
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Weinberg (biomedical entrepreneurship, Muhlenberg College in Allentown, Penn.) contributes three of the eight chapters in this volume on the background, development, and practice of Good Laboratory Practices (GLP). The topics include computer systems validation, FDA/GLP regulations, the FDA's GLP in
This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the
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.