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
| ISBN: | 9781032381152 |
| Publication date: | 9th October 2024 |
| Author: | Graham P Bunn |
| Publisher: | CRC Press |
| Format: | Paperback |
| Pagination: | 194 pages |
| Series: | Drugs and the Pharmaceutical Sciences |
| Genres: |
Medicine: general issues Pharmaceutical chemistry and technology Pharmacology Biology, life sciences |