Designed to enable readers to plan and execute their own audits,
this comprehensive guide presents both discussions 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 III
illustrates with examples the document requirements of the Quality
Assurance Unit and provides a clear understanding of its function.
Section IV comprises the full texts of the relevant standards and
regulations along with the Principles of Good Laboratory Practice.
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