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.

Contents

1. Good Laboratory Practices
   • Development of Regulations & Guidelines
   • The QA Unit
   • Quality Inspections & Audits
   • Contract Audits
   • System Audits
   • Internet Resources
   • Understanding GLP

2. QA Checklists
   • GLP Audit Checklist, Complete
   • Abbreviated GLP Audit Checklists

3. Document/Report Examples
   • Quality Assurance Documents
   • Inspection Report Examples

4. References/Regulatory Texts
   • includes the US FDA Good Laboratory Practice Regulations and the OECD Principles of Good Laboratory Practice

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