Good Laboratory Practice Regulations, Fourth Edition

Good Laboratory Practice Regulations, Fourth Edition

by Sandy Weinberg
     
 

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical

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Overview

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. 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 assurance of compliance in numerous research environments.

Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures…gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents…and details the FDA’s GLP inspection program.

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Editorial Reviews

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)

Product Details

ISBN-13:
9780849375835
Publisher:
Taylor & Francis
Publication date:
01/28/2007
Series:
Drugs and the Pharmaceutical Sciences Series, #168
Edition description:
REV
Pages:
304
Product dimensions:
6.20(w) x 9.10(h) x 0.90(d)

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