The Guide to Good Laboratory Practice Regulations: Interpretations and Compliance

By Graham P. Bunn

Are you involved in the pharmaceutical or medical device industry? If so, you probably understand the importance of compliance with Good Laboratory Practice (GLP) regulations. These regulations, enacted since 1978, ensure the quality and integrity of non-clinical laboratory studies that are submitted to the FDA.

Staying up-to-date with GLP regulations and understanding how to interpret and comply with them can be a daunting task. That’s where Graham P. Bunn’s book, “The Guide to Good Laboratory Practice Regulations: Interpretations and Compliance,” comes in. This unique volume provides a comprehensive and expert analysis of the 21CFR58 regulatory requirements, making it an invaluable resource for professionals in the industry.

The Importance of GLP Compliance

GLP compliance is of utmost importance in the pharmaceutical and medical device industry. It ensures that the non-clinical laboratory studies conducted to test the safety and efficacy of drugs and medical devices are reliable, accurate, and reproducible. Without proper adherence to GLP regulations, the validity of these studies may come into question, potentially delaying the approval process or even jeopardizing the safety of patients.

In “The Guide to Good Laboratory Practice Regulations,” Graham P. Bunn, an industry expert with extensive knowledge and experience, provides a detailed interpretation of the GLP regulations. This allows professionals working in GLP facilities to gain a deep understanding of the requirements and implement them effectively.

Expert Insights and Interpretations

One of the standout features of this book is the expert insights and interpretations provided by leading industry experts. These experts have a wealth of knowledge and expertise in their respective fields, making their interpretations and references incredibly valuable for GLP professionals.

The book covers a wide range of topics, including FDA inspections of GLP facilities, electronic data management in GLP, GLP and computer systems validation, and more. It addresses the recent advances in technology related to the industry, ensuring that professionals have the most up-to-date information at their fingertips.

Data Integrity and Electronic Systems

Data integrity is a crucial aspect of GLP compliance. The book delves into the intricacies of data integrity and discusses the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures. As technology continues to advance, it is important for professionals to understand how to maintain and ensure data integrity in the digital age.

Practical Implementation Support

While the book provides a comprehensive explanation of the GLP regulations, it is also designed to be a practical resource. Professionals can reference it repeatedly to support their daily implementation of the CFR requirements. This makes it an essential companion for GLP professionals seeking guidance and practical solutions.

Order Your Copy Today

If you work in the pharmaceutical or medical device industry, “The Guide to Good Laboratory Practice Regulations: Interpretations and Compliance” is a must-have resource. With its expert insights, comprehensive interpretations, and practical implementation support, this book is an invaluable tool for ensuring GLP compliance.

Order your copy today and take your understanding of GLP regulations to the next level. Stay up-to-date with the latest advances in technology and enhance your ability to conduct reliable and accurate non-clinical laboratory studies.

Product Details

• Publisher ‏ : ‎ CRC Press; 1st edition (December 13, 2022)
• Language ‏ : ‎ English
• Hardcover ‏ : ‎ 206 pages
• ISBN-10 ‏ : ‎ 0367336278
• ISBN-13 ‏ : ‎ 978-0367336271