Good Laboratory Practice for Nonclinical Studies (Hardcover)

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. * Unique volume covering FDA inspections of GLP facilities * Provides a detailed interpretation of GLP Regulations * Presents the latest on electronic data management in GLP * Describes GLP and computer systems validation * Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Series:	Drugs and the Pharmaceutical Sciences
Release date:	December 2022
First published:	2023
Editors:	Graham P. Bunn
Dimensions:	234 x 156 x 19mm (L x W x T)
Format:	Hardcover
Pages:	194
ISBN-13:	978-0-367-33627-1
Categories:	Books > Medicine > General issues > General Books > Science & Mathematics > Biology, life sciences > General Books > Medicine > Other branches of medicine > Pharmacology > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	0-367-33627-8
Barcode:	9780367336271

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