Good Laboratory Practice for Nonclinical Studies
商品資訊
系列名：Drugs and the Pharmaceutical Sciences
ISBN13：9780367336271
出版社：PBKTYFRL
作者：Bunn; Graham P. (President; GB Consulting LLC; PA; USA)
出版日：2022/12/06
裝訂／頁數：精裝／192頁
規格：15.6cm*23.4cm (高/寬)
商品簡介
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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