Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.