CRC Press; 1st edition (December 13, 2022)
Graham P. Bunn
978-0367336271, 9780367336271, 9780429323393, 9781032381152
Good Laboratory Practice for Nonclinical Studies – Original PDF
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.