Medical & Biomedical Technology - General & Miscellaneous, Laboratory Medicine, Medical & Health Care Quality Control, Laboratories
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Overview
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.
The book contains black-and-white illustrations.
Editorials
Booknews
Discusses the Good Laboratory Practice Regulations promulgated by the US Food and Drug Administration in 1976 and frequently revised since then, how to implement them, why they should be followed even in laboratories not legally subject to them, and how they fit into the larger picture of US and global regulation and practice. Discusses the historical development of the regulations, automated laboratories, computer systems, validation, the FDA's inspection program, and the cybernetic necessity for the regulations. Emphasizes the importance of a quality assurance unit, a director with ultimate responsibility, written protocols, and well maintained and calibrated instruments. No date is noted for the first edition. Annotation c. Book News, Inc., Portland, OR (booknews.com)Book Details
Published
November 6, 2002
Publisher
Marcel Dekker Inc
Pages
264
Format
Hardcover
ISBN
9780824708917