ABSTRACT

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.

section Section I

Good Laboratory Practices

chapter Chapter 1|6 pages

Development of Regulations and Guidelines

chapter Chapter 2|14 pages

The Quality Assurance Unit

chapter Chapter 3|15 pages

Quality Inspections and Audit

chapter Chapter 4|7 pages

Contract Laboratory Audits

chapter Chapter 5|6 pages

System Audits

chapter Chapter 6|15 pages

Internet Resources

chapter Chapter 7|9 pages

Contributions to GLP Understanding

section Section II|100 pages

Quality Audit Checklists

section Section III|16 pages

Document/Report Examples

chapter |7 pages

Quality Assurance Documents

chapter |8 pages

Inspection Report Examples

section Section IV|222 pages

Reference/Regulatory Texts

chapter |57 pages

Guidance for Industry