GLP Quality Audit Manual  book cover
SAVE
$13.99
3rd Edition

GLP Quality Audit Manual





ISBN 9780367398439
Published May 27, 2020 by CRC Press
464 Pages

 
SAVE ~ $13.99
was $69.95
USD $55.96

Prices & shipping based on shipping country


Preview

Book Description

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.

Table of Contents

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.

...
View More

Author(s)

Biography

Anderson, Milton A.