Good Laboratory Practice for Nonclinical Studies

This book provides a comprehensive interpretation of the 21CFR58 regulatory requirements, offering insights from industry experts and covering topics such as data integrity, electronic systems, and GLP facility inspections. It is a valuable resource for those involved in compliance with GLP regulations.

Format: Hardback
Length: 194 pages
Publication date: 13 December 2022
Publisher: Taylor & Francis Ltd

The GLP regulations have been in effect since 1978 and are currently undergoing a proposed FDA amendment to update terminology and incorporate other changes related to advancements in technology within the industry. This comprehensive book offers a rare opportunity to gain insights into the interpretation of 21CFR58 regulatory requirements from esteemed industry experts possessing extensive knowledge and expertise in their respective fields. The approach employed in this text takes the regulations as a foundation, provides comprehensive interpretations, and includes references to relevant examples and regulatory actions. Additionally, it delves into the importance of data integrity and the utilization of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures.

This unique volume specifically focuses on FDA inspections of GLP facilities, providing a detailed account of the regulatory processes and practices. It offers valuable insights into the compliance requirements and expectations of GLP, ensuring that readers are well-informed about the necessary standards and procedures.

Furthermore, the book provides a comprehensive interpretation of GLP Regulations, covering key aspects such as facility design, personnel qualifications, equipment maintenance, and recordkeeping. It serves as a valuable resource for individuals involved in GLP-related activities, helping them to understand and apply the regulations effectively.

In addition to the interpretation of regulations, the book also delves into the latest developments in electronic data management within GLP. It discusses the use of electronic systems and tools to streamline data collection, analysis, and reporting, ensuring the accuracy and reliability of GLP data. This topic is particularly relevant in today's digital age, where the use of technology plays a crucial role in scientific research and regulatory compliance.

Furthermore, the book provides a detailed description of GLP and computer systems validation, a critical aspect of ensuring the accuracy and reliability of electronic records and data. It discusses the principles and practices of validation, including the development and implementation of validation protocols, testing strategies, and documentation requirements. This information is essential for organizations involved in GLP-related activities, as it helps them to meet the regulatory standards and ensure the quality and integrity of their data.

Overall, this comprehensive book offers a valuable resource for individuals, organizations, and regulatory bodies involved in GLP-related activities. It provides a detailed interpretation of the regulations, insights into electronic data management, and discussions on GLP and computer systems validation. By referencing this text repeatedly, readers can gain a deep understanding of the CFR requirements and implement them effectively in their daily operations.

Weight: 430g
Dimension: 163 x 240 x 19 (mm)
ISBN-13: 9780367336271