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.
SECTION I: GOOD LABORATORY PRACTICES
Development of Regulations & Guidelines
The QA Unit
Quality Inspections & Audits
SECTION II: QA CHECKLISTS
GLP Audit Checklist, Complete
Abbreviated GLP Audit Checklists
SECTION III: DOCUMENT/REPORT EXAMPLES
Quality Assurance Documents
Inspection Report Examples
SECTION IV: REFERENCES/REGULATORY TEXTS
include the US FDA Good Laboratory Practice Regulations and the OECD Principles of Good Laboratory Practice.