Good Laboratory Practice Regulations, Fourth Edition (Drugs and the Pharmaceutical Sciences)

Description

Good Laboratory Practice Regulations, Fourth Edition (Drugs and the Pharmaceutical Sciences)

Publisher: Informa Healthcare
Number Of Pages: 285
Publication Date: 2007-01-19
Sales Rank: 679244
ISBN / ASIN: 0849375835
EAN: 9780849375835
Binding: Hardcover
Manufacturer: Informa Healthcare
Studio: Informa Healthcare

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.

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