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. Contract Audits. System Audits. Internet Resources. Understanding GLP. 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.