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Good Laboratory Practice for Nonclinical Studies
Hardcover
Series: Drugs and the Pharmaceutical Sciences
Medical ReferenceChemistryGeneral Science
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ISBN13: 9780367336271
Publisher: Crc Pr Inc
Published: Dec 13 2022
Pages: 194
Language: English
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
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